Codman Catheter/Synchromed Pump Hepatic Artery Chemothera... | NCT04276090

Label	Type	Description	Intervention Names
Colorectal liver metastases	Experimental	Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type)	Device: Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Drug: Hepatic artery infusion pump floxuridine and dexamethasone Drug: Systemic chemotherapy for colorectal liver metastases
Intrahepatic cholangiocarcinoma	Experimental	Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone)	Device: Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Drug: Hepatic artery infusion pump floxuridine and dexamethasone Drug: Systemic chemotherapy for intrahepatic cholangiocarcinoma

Name	Type	Description	Arm Group Labels	Other Names
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.	Device	Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.

Measure	Description	Time Frame
Percent Completion of 1st Cycle of Hepatic Artery Chemotherapy	The percent of patients who complete the 1st cycle of hepatic artery chemotherapy will be tabulated. This is a conglomerate safety endpoint which is a surrogate for any complication that prevents delivery of hepatic artery chemotherapy via the device combination.	approximately 4 weeks

Measure	Description	Time Frame
30-day Postoperative Serious Adverse Events Related to Pump Implantation	Tabulation of CTCAE serious adverse events attributed to pump implantation	30 days
30-day Catheter Malfunction Due to Tubing Disconnect

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients ≥ 18 years of age
Histologically confirmed unresectable colorectal adenocarcinoma metastatic to the liver with no definitive clinical or radiographic evidence of extrahepatic disease. Clinical or radiographic evidence of metastatic disease to peri-hepatic lymph nodes will be allowed, provided it is amenable to resection.

(OR)

Histologically confirmed unresectable non-metastatic intrahepatic cholangiocarcinoma, with presence of less than 70% liver involvement. Clinical or radiographic evidence of metastatic disease to peri-hepatic lymph nodes will be allowed, provided it is amenable to resection.
ECOG Performance Status of 0 - 1
Lab Values ≤ 14 days prior to study enrollment:

absolute neutrophil count ≥1,500/mcL AST/ALT < 2.5 x institutional upper limit of normal (ULN) Platelets ≥ 100,000/mcL Creatinine < 1.5 mg/dL HGB > 9 g/dL Total Bilirubin ≤ 1.5 mg/dL

Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Prior chemotherapy is acceptable if last dose given ≥ 3 weeks prior to study enrollment.
Any investigational agent is acceptable if last dose administered ≥ 3 months before study enrollment.

Exclusion Criteria:

Presence of distant metastatic disease confirmed by radiographic evaluation. Clinical or radiographic evidence of metastatic disease to regional peri-hepatic lymph nodes will be allowed, provided it is amenable to resection.
Prior radiation to the liver, including external beam, SBRT, Y90. Prior radiation therapy to the pelvis is acceptable.
Active infection, hepatic encephalopathy
Clinical evidence of portal hypertension (ascites, gastroesophageal varices or portal vein thrombosis; surgically-related ascites does not exclude the patient)
Female patients who are pregnant or lactating - or planning to become pregnant within 6 months after the end of the treatment (female patients of child-bearing potential must have negative pregnancy test ≤72 hours before surgery)
If in the opinion of the treating investigator a patient has any serious medical problems which may preclude receiving this type of treatment
Patients with history or known presence of primary CNS tumors, seizures not well-controlled with standard medical therapy, or history of stroke
Serious or non-healing active wound, ulcer, or bone fracture
Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the HAIP chemotherapy (i.e., investigational regimen)
Patients with psychiatric illness or social situations that would limit compliance with study requirements. Examples include: active substance abuse, active severe EtOH abuse, etc.
Inability to reliably commit to traveling to Lexington, KY every 2 weeks for duration of the study treatment (6 months). Patient must have readily identifiable, reliable primary and back-up modes of transportation regardless of weather.

Name	Affiliation	Role
Michael J Cavnar, MD	University of Kentucky	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Kentucky		Lexington	Kentucky	40536	United States

PubMed Identifier	Type	Citation	Retractions
36410913	Derived	McDonald HG, Cassim EB, Harper MM, Burke EE, Marcinkowski EF, Cavnar MJ, Pandalai PK, Kim J. The Development of Investigator-Initiated Clinical Trials in Surgical Oncology. Surg Oncol Clin N Am. 2023 Jan;32(1):13-25. doi: 10.1016/j.soc.2022.07.003. Epub 2022 Nov 3.

ID	Title	Description
FG000	Colorectal Liver Metastases	Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP_ICF	Yes	Yes	Yes	Study Protocol, Statistical Analysis Plan, and Informed Consent Form	Dec 19, 2022

Arm/Group Information

ID	Title	Description
BG000	Colorectal Liver Metastases	Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
BG001	Intrahepatic Cholangiocarcinoma	Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00017 BG0014 BG00221

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percent Completion of 1st Cycle of Hepatic Artery Chemotherapy

The percent of patients who complete the 1st cycle of hepatic artery chemotherapy will be tabulated. This is a conglomerate safety endpoint which is a surrogate for any complication that prevents delivery of hepatic artery chemotherapy via the device combination.

Posted

Count of Participants

Participants

approximately 4 weeks

ID	Title	Description
OG000	Colorectal Liver Metastases	Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
OG001	Intrahepatic Cholangiocarcinoma	Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)

Units	Counts
Participants	OG00017 OG0014

Title

Denominators

Categories

Title	Measurements
	OG00016 OG0014

Secondary

30-day Postoperative Serious Adverse Events Related to Pump Implantation

Tabulation of CTCAE serious adverse events attributed to pump implantation

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	Colorectal Liver Metastases	Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
OG001	Intrahepatic Cholangiocarcinoma	Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)

Secondary

30-day Catheter Malfunction Due to Tubing Disconnect

Quantify the percent of patients with inability to meet primary outcome due to catheter disconnects.

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	Colorectal Liver Metastases	Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
OG001	Intrahepatic Cholangiocarcinoma	Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)

Secondary

30-day Catheter Malfunction Due to Inability to Access Pump

Quantify the percent of patients with inability to meet primary outcome due to inability to access pump.

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	Colorectal Liver Metastases	Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
OG001	Intrahepatic Cholangiocarcinoma	Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)

Secondary

Percent of Patients That Require Secondary Intervention in Order to Obtain Primary Pump Function.

Percentage of patients who need secondary intervention (IR embolization, revision of pump or tubing) to achieve primary pump function.

Posted

Count of Participants

Participants

Approximately 4 weeks

ID	Title	Description
OG000	Colorectal Liver Metastases	Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
OG001	Intrahepatic Cholangiocarcinoma	Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)

Secondary

Percent of Screened Patients That Are Declined Due to High Risk of Failure as Determined by the Psychosocial Assessment Tool.

Patients are screen using a psychosocial assessment tool for high risk of hepatic artery pump loss/failure, percent declined will be tabulated.

Posted

Count of Participants

Participants

Immediate, determined at screening visit

ID	Title	Description
OG000	Colorectal Liver Metastases	Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
OG001	Intrahepatic Cholangiocarcinoma	Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)

Secondary

Percent Pump Loss Due to Inability to Attend Scheduled Followup Appointments.

Percent of patients that experience pump loss/failure due to inability to attend scheduled followup appointments will be tabulated.

Posted

Count of Participants

Participants

Approximately 6 months

ID	Title	Description
OG000	Colorectal Liver Metastases	Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
OG001	Intrahepatic Cholangiocarcinoma	Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)

Secondary

Number of Interventions (Phone Calls) to Assure Patients Attend Followup Appointments.

The number of staff contacts (phone calls) to assure patients keep their followup visits will be tabulated.

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	Colorectal Liver Metastases	Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
OG001	Intrahepatic Cholangiocarcinoma	Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)

Secondary

Percent of Patients Who Remain on Hepatic Artery Infusion Pump Chemotherapy at 3 Months.

The percentage of patients who remain on pump chemotherapy at 3 months will be tabulated.

Posted

Count of Participants

Participants

3 months

ID	Title	Description
OG000	Colorectal Liver Metastases	Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
OG001	Intrahepatic Cholangiocarcinoma	Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)

Secondary

Overall Response Rate at 6 Months

RECIST v1.1 will be used to assess overall response rate at 6 months.

At the 6 month time point for this outcome there were only 14 evaluable participants for response rate due to attrition, death, or sub-RECIST threshold disease.

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	Colorectal Liver Metastases	Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
OG001	Intrahepatic Cholangiocarcinoma

Secondary

Percent of Patients Who Are Downstaged and Undergo Surgery

The percent of patients who are downstaged and undergo surgery will be tabulated.

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	Colorectal Liver Metastases	Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
OG001	Intrahepatic Cholangiocarcinoma	Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)

Secondary

Percent of Patients Who Remain on Hepatic Artery Infusion Pump Chemotherapy at 6 Months.

The percentage of patients who remain on pump chemotherapy at 6months will be tabulated.

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	Colorectal Liver Metastases	Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
OG001	Intrahepatic Cholangiocarcinoma	Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Colorectal Liver Metastases	Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for colorectal liver metastases: Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)	3	17	15	17	17	17
EG001	Intrahepatic Cholangiocarcinoma	Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone) Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.: Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Hepatic artery infusion pump floxuridine and dexamethasone: Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump Systemic chemotherapy for intrahepatic cholangiocarcinoma: Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)	2	4	2	4	4	4

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected4 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Other	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected4 at risk
Disease progression	General disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Other	Infections and infestations	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Sepsis	Immune system disorders	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected4 at risk
Neutrophil count decreased	Investigations	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
White blood cell count decreased	Investigations	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Lymphocyte count decreased	Investigations	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Creatinine increased	Investigations	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Hyponatremia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Acute kidney injury	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	Systematic Assessment	EG00015 events15 affected17 at risk EG0013 events3 affected4 at risk
Other	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Sinus tachycardia	Cardiac disorders	Systematic Assessment	EG0006 events6 affected17 at risk EG0010 events0 affected4 at risk
Ventricular tachycardia	Cardiac disorders	Systematic Assessment	EG0004 events4 affected17 at risk EG0011 events1 affected4 at risk
Abdominal distension	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected4 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0007 events7 affected17 at risk EG0012 events2 affected4 at risk
Ascites	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0005 events5 affected17 at risk EG0012 events2 affected4 at risk
Diarrhea	Gastrointestinal disorders	Systematic Assessment	EG00011 events11 affected17 at risk EG0012 events2 affected4 at risk
Other	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected17 at risk EG0011 events1 affected4 at risk
Gastroparesis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Ileus	Gastrointestinal disorders	Systematic Assessment	EG0004 events4 affected17 at risk EG0010 events0 affected4 at risk
Mucisitis Oral	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected4 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG00014 events14 affected17 at risk EG0012 events2 affected4 at risk
Oral pain	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0006 events6 affected17 at risk EG0012 events2 affected4 at risk
Edema limbs	General disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected4 at risk
Fatigue	General disorders	Systematic Assessment	EG00012 events12 affected17 at risk EG0012 events2 affected4 at risk
Fever	General disorders	Systematic Assessment	EG0003 events3 affected17 at risk EG0010 events0 affected4 at risk
Pain	General disorders	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected4 at risk
Bruising	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected4 at risk
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Seroma	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Wound complication	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Alanine aminotransferase increased	Investigations	Systematic Assessment	EG00017 events17 affected17 at risk EG0014 events4 affected4 at risk
Alkaline phosphatase increased	Investigations	Systematic Assessment	EG00014 events14 affected17 at risk EG0013 events3 affected4 at risk
Aspartate aminotransferase increased	Investigations	Systematic Assessment	EG00017 events17 affected17 at risk EG0014 events4 affected4 at risk
Blood bilirubin increased	Investigations	Systematic Assessment	EG00010 events10 affected17 at risk EG0012 events2 affected4 at risk
Blood lactate dehydrogenase increased	Investigations	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected4 at risk
Creatinine increased	Investigations	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected4 at risk
INR increased	Investigations	Systematic Assessment	EG0002 events2 affected17 at risk EG0011 events1 affected4 at risk
Lipase increased	Investigations	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Lymphocyte count decreased	Investigations	Systematic Assessment	EG00011 events11 affected17 at risk EG0013 events3 affected4 at risk
Neutrophil count decreased	Investigations	Systematic Assessment	EG0007 events7 affected17 at risk EG0012 events2 affected4 at risk
Platelet count decreased	Investigations	Systematic Assessment	EG0007 events7 affected17 at risk EG0014 events4 affected4 at risk
White blood cell decreased	Investigations	Systematic Assessment	EG0005 events5 affected17 at risk EG0012 events2 affected4 at risk
Anorexia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 events3 affected17 at risk EG0013 events3 affected4 at risk
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected4 at risk
Hyperglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG0008 events8 affected17 at risk EG0012 events2 affected4 at risk
Hyperkalemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 events3 affected17 at risk EG0011 events1 affected4 at risk
Hypermagnesemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected4 at risk
Hypernatremia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Hypophosphatemia	Metabolism and nutrition disorders	Systematic Assessment	EG00011 events11 affected17 at risk EG0013 events3 affected4 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Muscle cramp	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Dysarthria	Nervous system disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Hypersomnia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Other	Nervous system disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected4 at risk
Paresthesia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Peripheral sensory neuropathy	Nervous system disorders	Systematic Assessment	EG0006 events6 affected17 at risk EG0012 events2 affected4 at risk
Somnolence	Nervous system disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Delirium	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Urinary retention	Renal and urinary disorders	Systematic Assessment	EG0004 events4 affected17 at risk EG0010 events0 affected4 at risk
Erectile dysfunction	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Genital edema	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected4 at risk
Other	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Alopecia	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0003 events3 affected17 at risk EG0010 events0 affected4 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected4 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0003 events3 affected17 at risk EG0011 events1 affected4 at risk
Other	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 events2 affected17 at risk EG0011 events1 affected4 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected4 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected4 at risk
Febrile neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected4 at risk
Bloating	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected4 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected4 at risk
Chills	General disorders	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected4 at risk
Hyperphosphatemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected17 at risk EG0011 events1 affected4 at risk
Hypoalbuminemia	Metabolism and nutrition disorders	Systematic Assessment	EG00011 events11 affected17 at risk EG0014 events4 affected4 at risk
Hypocalcemia	Metabolism and nutrition disorders	Systematic Assessment	EG00014 events14 affected17 at risk EG0013 events3 affected4 at risk
Hypokalemia	Metabolism and nutrition disorders	Systematic Assessment	EG00013 events13 affected17 at risk EG0014 events4 affected4 at risk
Hypomagnesemia	Metabolism and nutrition disorders	Systematic Assessment	EG00012 events12 affected17 at risk EG0013 events3 affected4 at risk
Hyponatremia	Metabolism and nutrition disorders	Systematic Assessment	EG00010 events10 affected17 at risk EG0013 events3 affected4 at risk
Flank pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected4 at risk
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected17 at risk EG0014 events4 affected4 at risk

ID	Term
D001650	Bile Duct Neoplasms
D015179	Colorectal Neoplasms
D018281	Cholangiocarcinoma

ID	Term
D001661	Biliary Tract Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D001649	Bile Duct Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated