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Slow enrollment
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The study planned to evaluate the benefit of applying Selective Internal Radiation Therapy (SIRT) using SIR-Spheres Y-90 resin microspheres prior to receiving systemic chemotherapy treatment (cisplatin-gemcitabine, or CIS-GEM) in patients with unresectable intrahepatic cholangiocarcinoma. Half of the patients were randomized to CIS-GEM chemotherapy plus SIRT, and half of the patients were randomized to CIS-GEM alone.
This clinical study was a prospective, multicenter, randomized, controlled study evaluating SIR-Spheres Y-90 resin microspheres followed by cisplatin-gemcitabine (CIS-GEM) chemotherapy vs. CIS-GEM chemotherapy alone as first-line treatment of patients with unresectable intrahepatic cholangiocarcinoma.
Randomized patients were to be followed until death, withdrawal of consent, or until end of study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy (Cisplatin-Gemcitabine) | Active Comparator | Cisplatin 25mg/m2 in 1000ml 0.9% saline given over 1 hour followed by 500 ml 0.9% saline over 30 minutes, followed by Gemcitabine 1000 mg/m2 in 250-500 ml 0.9% saline over 30 minutes by intravenous infusions on days 1, and 8 of a 21-day cycle. |
|
| Radiation: SIRT + chemotherapy (Cisplatin-Gemcitabine) | Experimental | A single treatment of hepatic arterial injection of SIR-Spheres Y-90 resin microspheres (SIRT) followed 14-16 days later by systemic chemotherapy (ABC-02 CIS-GEM protocol) with an intention to treat with 8 cycles of cisplatin + gemcitabine, or until progression, toxicity or patient choice. Treatment may be continued beyond 8 cycles in the absence of significant disease progression, at the treating clinicians' discretion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin-gemcitabine | Drug | Systemic chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival at 18 Months | Survival at 18 months is defined as the proportion of patients still alive 18 months from the date of randomization. The outcome was analyzed but the clinical database is not deemed to be reliable. | 18 months following the date of randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| Liver-specific Progression Free Survival (PFS) | Liver-specific PFS was defined as the number of days between randomization and the date of first tumor progression in the liver. Diagnosis of tumor progression was to be made using RECIST 1.1. | From date of randomization to the first documented date of progression in the liver or date of death from any cause, assessed up to 36 months.. |
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Inclusion Criteria:
Hemoglobin >/= 10g/dL White Blood Cell count (WBC) >/= 3.0 x 10^9/L Absolute neutrophil count (ANC) >/= 1.5 x 10^9/L Platelet count >/= 100,000/mm^3 - Adequate liver function defined as: Total bilirubin </= 30 umol/L (1.75 mg/dL) Albumin >/= 30 g/L
- Adequate renal function defined as: Serum urea and serum creatinine < 1.5 times upper limit of normal (ULN) Creatinine clearance >/= 45 ml/min (calculated with Cockcroft-Gault Equation)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jordi Bruix, MD | Head of the Hepatic Oncology Unit, Hospital Clinic | Principal Investigator |
| Harpreet Wasan, MD | Imperial College Healthcare Hammersmith Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Health Care | Spokane | Washington | 99204 | United States | ||
| Macquarie University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40812353 | Derived | Blair AB, Alobuia WM, Palta M, Raman SS, Levine MH, Benson AB 3rd, D'Angelica MI, Cloyd JM. Locoregional Treatment Options for Locally Advanced Intrahepatic Cholangiocarcinoma. J Natl Compr Canc Netw. 2025 Aug 14;23(9):e257085. doi: 10.6004/jnccn.2025.7085. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemotherapy (Cisplatin-Gemcitabine) | Cisplatin 25mg/m2 in 1000ml 0.9% saline given over 1 hour followed by 500 ml 0.9% saline over 30 minutes, followed by Gemcitabine 1000 mg/m2 in 250-500 ml 0.9% saline over 30 minutes by intravenous infusions on days 1, and 8 of a 21-day cycle. Cisplatin-gemcitabine: Systemic chemotherapy |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 12, 2019 |
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| Radiation: SIRT + chemotherapy (cisplatin-gemcitabine) | Device | SIR-Spheres microspheres followed by systemic chemotherapy |
|
| Progression Free Survival (PFS) at Any Site | PFS was defined as the time interval between randomization and the date of tumor progression. Diagnosis of tumor progression was to be made using RECIST 1.1. The outcome was not analyzed due to unreliability of the clinical database. | From date of randomization to the date of progression at any site until the first date of documented tumor progression at any site or date of death from any cause, assessed up to 36 months. |
| Objective Response Rate by RECIST 1.1 and Refined RECIST - Liver | The outcome was not analyzed due to unreliability of the clinical database. | From the date of first treatment until the date of date of first documented progression in the liver, assessed up to 36 months. |
| Objective Response Rate by RECIST 1.1 and Refined RECIST - at Any Site | The outcome was not analyzed due to unreliability of the clinical database. | From the date of first treatment until progression at any site, assessed up to 36 months. |
| Overall Survival | The outcome was not analyzed due to unreliability of the clinical database. | From date of randomization until the date of death from any cause, assessed up to 36 months. |
| Liver Surgical Resection and Ablation Rate | To assess the number of patients in each arm who are downstaged by protocol therapy and can proceed to liver resection or ablation. The specific assessments will be the classification of resection as R0, R1 or R2, the presence of viable tumor or fibrosis, and the nearest resection margin. The outcome was not analyzed due to unreliability of the clinical database. | 18 months following the date of randomization. |
| Incidence of Adverse Events (Safety and Tolerability) | Adverse events (AEs) as assessed by CTCAE v. 4.0. Summaries of non-serious AEs (clinical database, MedDRA 20.1) and serious adverse events (SAEs; pharmacovigilance database, MedDRA 25.1) are provided for information only in the 'Adverse Events' section - the data are deemed unreliable. | Informed consent until 28 days post last dose of protocol chemotherapy. |
| North Ryde |
| New South Wales |
| 2109 |
| Australia |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| Hopital Beaujon | Clichy | 92110 | France |
| CHU Dijon | Dijon | 21079 | France |
| CHU de Grenoble | Grenoble | 38043 | France |
| CHU Lyon - Hospital de la Croix-Rousse | Lyon | 69317 | France |
| Institut Paoli Calmettes | Marseille | 13009 | France |
| CHU Montpellier | Montpellier | 34295 | France |
| CHU Nice - Hopital l'Archet 2 | Nice | 06202 | France |
| Hopital Haut-Leveque | Pessac | 33604 | France |
| CHU de Poitiers | Poitiers | 86021 | France |
| Centre Eugene Marquis Hospital de Jour | Rennes | 35042 | France |
| Hopital Paul Brousse | Villejuif | 94800 | France |
| U.O. Oncologia Medica 2 Universitaria | Pisa | 56126 | Italy |
| AMC Academic Medical Center | Amsterdam | 1105 | Netherlands |
| Hospital Clinic Barcelona | Barcelona | 08036 | Spain |
| Clinica Universitaria de Navarra | Pamplona | 31008 | Spain |
| Hammersmith Hospital Imperial College Healthcare NHS Trust | London | W12 0HS | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| The Clatterbridge Cancer Centre NHS Foundation Trust | Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
| Southampton General Hospital | Southampton | S016 6YD | United Kingdom |
| Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine) |
A single treatment of hepatic arterial injection of SIR-Spheres Y-90 resin microspheres (SIRT) followed 14-16 days later by systemic chemotherapy (ABC-02 CIS-GEM protocol) with an intention to treat with 8 cycles of cisplatin + gemcitabine, or until progression, toxicity or patient choice. Treatment may be continued beyond 8 cycles in the absence of significant disease progression, at the treating clinicians' discretion. Cisplatin-gemcitabine: Systemic chemotherapy Radiation: SIRT + chemotherapy (cisplatin-gemcitabine): SIR-Spheres microspheres followed by systemic chemotherapy |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chemotherapy (Cisplatin-Gemcitabine) | Cisplatin 25mg/m2 in 1000ml 0.9% saline given over 1 hour followed by 500 ml 0.9% saline over 30 minutes, followed by Gemcitabine 1000 mg/m2 in 250-500 ml 0.9% saline over 30 minutes by intravenous infusions on days 1, and 8 of a 21-day cycle. Cisplatin-gemcitabine: Systemic chemotherapy |
| BG001 | Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine) | A single treatment of hepatic arterial injection of SIR-Spheres Y-90 resin microspheres (SIRT) followed 14-16 days later by systemic chemotherapy (ABC-02 CIS-GEM protocol) with an intention to treat with 8 cycles of cisplatin + gemcitabine, or until progression, toxicity or patient choice. Treatment may be continued beyond 8 cycles in the absence of significant disease progression, at the treating clinicians' discretion. Cisplatin-gemcitabine: Systemic chemotherapy Radiation: SIRT + chemotherapy (cisplatin-gemcitabine): SIR-Spheres microspheres followed by systemic chemotherapy |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Extra-hepatic disease | Count of Participants | Participants |
| ||||||||||||||||||
| ECOG Performance Scale | Eastern cooperative oncology group (ECOG) performance status 0 versus 1 as per the study inclusion criterion. 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light housework, office work. | Count of Participants | Participants |
| |||||||||||||||||
| Cirrhosis | Count of Participants | Participants |
| ||||||||||||||||||
| Extent of liver involvement | Count of Participants | Participants |
| ||||||||||||||||||
| Prior Treatment | Count of Participants | Participants |
|
| 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 | Survival at 18 Months | Survival at 18 months is defined as the proportion of patients still alive 18 months from the date of randomization. The outcome was analyzed but the clinical database is not deemed to be reliable. | Randomized Population | Posted | Count of Participants | Participants | 18 months following the date of randomization. |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Liver-specific Progression Free Survival (PFS) | Liver-specific PFS was defined as the number of days between randomization and the date of first tumor progression in the liver. Diagnosis of tumor progression was to be made using RECIST 1.1. | The data set we received for analysis showed only 17 CIS-GEM participants and 16 SIRT+CIS GEM participants with reported liver tumor progression data available. Due to database issues, the validity and reliability of this data is not complete. | Posted | Mean | Full Range | Days to first tumor progression | From date of randomization to the first documented date of progression in the liver or date of death from any cause, assessed up to 36 months.. |
| ||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) at Any Site | PFS was defined as the time interval between randomization and the date of tumor progression. Diagnosis of tumor progression was to be made using RECIST 1.1. The outcome was not analyzed due to unreliability of the clinical database. | The data set we received for analysis showed 38 CIS-GEM participants and 27 SIRT+CIS GEM participants with reported tumor progression data available for any site. Due to database issues, the validity and reliability of this data is not complete | Posted | Mean | Full Range | Days to tumor progression | From date of randomization to the date of progression at any site until the first date of documented tumor progression at any site or date of death from any cause, assessed up to 36 months. |
| ||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate by RECIST 1.1 and Refined RECIST - Liver | The outcome was not analyzed due to unreliability of the clinical database. | The data we received showed 85 of our 89 subjects with any RECIST data present. These data were not available nor complete for each visit due to early study termination and database issues. Any available data is reflected in the table. The validity and reliability of these data are not complete. | Posted | Count of Units | Number of Responses (RECIST 1.1+RRECIST) | From the date of first treatment until the date of date of first documented progression in the liver, assessed up to 36 months. | Number of Responses (RECIST 1.1+RRECIST) | Number of Responses (RECIST 1.1+RRECIST) |
| |||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate by RECIST 1.1 and Refined RECIST - at Any Site | The outcome was not analyzed due to unreliability of the clinical database. | The data we received showed 85 of our 89 subjects with any RECIST data present. These data were not available nor complete for each visit due to early study termination and database issues. Any available data is reflected in the table. The validity and reliability of these data are not complete. | Posted | Count of Units | Number of Responses (RECIST 1.1+RRECIST) | From the date of first treatment until progression at any site, assessed up to 36 months. | Number of Responses (RECIST 1.1+RRECIST) | Number of Responses (RECIST 1.1+RRECIST) |
| |||||||||||||||||||||||||||||||
| Secondary | Overall Survival | The outcome was not analyzed due to unreliability of the clinical database. | Overall survival data assessed until 36 months can be calculated for 42 CIS GEM participants and 36 SIRT+CIS GEM participants due to early termination and database errors. The validity and reliability of these data are not complete. | Posted | Count of Participants | Participants | From date of randomization until the date of death from any cause, assessed up to 36 months. |
| |||||||||||||||||||||||||||||||||
| Secondary | Liver Surgical Resection and Ablation Rate | To assess the number of patients in each arm who are downstaged by protocol therapy and can proceed to liver resection or ablation. The specific assessments will be the classification of resection as R0, R1 or R2, the presence of viable tumor or fibrosis, and the nearest resection margin. The outcome was not analyzed due to unreliability of the clinical database. | Data were collected for only 14 unique patients within the study due to early study termination and database issues. Any available data are reflected in the table. The validity and reliability of these data are not complete. | Posted | Count of Participants | Participants | 18 months following the date of randomization. |
| |||||||||||||||||||||||||||||||||
| Secondary | Incidence of Adverse Events (Safety and Tolerability) | Adverse events (AEs) as assessed by CTCAE v. 4.0. Summaries of non-serious AEs (clinical database, MedDRA 20.1) and serious adverse events (SAEs; pharmacovigilance database, MedDRA 25.1) are provided for information only in the 'Adverse Events' section - the data are deemed unreliable. | The following endpoints reflects safety and tolerability data related to Adverse Event grade by category. Counts of participants with Grade 3 or higher adverse event severity by AE category by treatment arm are shown below. | Posted | Count of Participants | Participants | Informed consent until 28 days post last dose of protocol chemotherapy. |
|
Up to 3.6 years
AEs from time of informed consent up to 28 days post last dose of chemo, and any treatment-related (TR) AEs at any time were recorded. SAEs and TR AEs were followed until resolution, death, or end of study. Per protocol, disease progression events were not considered AEs, but lack of efficacy. If any disease progression events occurred, no data was collected, and they were not documented in the database. All recorded AEs that met the Results Data Element Definitions were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chemotherapy (Cisplatin-Gemcitabine) | Cisplatin 25mg/m2 in 1000ml 0.9% saline given over 1 hour followed by 500 ml 0.9% saline over 30 minutes, followed by Gemcitabine 1000 mg/m2 in 250-500 ml 0.9% saline over 30 minutes by intravenous infusions on days 1, and 8 of a 21-day cycle. Cisplatin-gemcitabine: Systemic chemotherapy | 28 | 48 | 17 | 48 | 47 | 48 |
| EG001 | Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine) | A single treatment of hepatic arterial injection of SIR-Spheres Y-90 resin microspheres (SIRT) followed 14-16 days later by systemic chemotherapy (ABC-02 CIS-GEM protocol) with an intention to treat with 8 cycles of cisplatin + gemcitabine, or until progression, toxicity or patient choice. Treatment may be continued beyond 8 cycles in the absence of significant disease progression, at the treating clinicians' discretion. Cisplatin-gemcitabine: Systemic chemotherapy Radiation: SIRT + chemotherapy (cisplatin-gemcitabine): SIR-Spheres microspheres followed by systemic chemotherapy | 24 | 41 | 21 | 41 | 41 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Aortic valve disease | Cardiac disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Diaphragmatic hernia | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Haemoperitoneum | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Spigelian hernia | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Strangulated hernia | General disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Haemobilia | Hepatobiliary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hepatic pain | Hepatobiliary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Campylobacter infection | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pneumocytis jirovecii pneumonia | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
| |
| Post embolization syndrome | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
| |
| Procedural shock | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
| |
| Radiation hepatitis | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 25.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Posterior reversable encephalopathy syndrome | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
| |
| Aortic valve replacement | Surgical and medical procedures | MedDRA 25.1 | Non-systematic Assessment |
| |
| Drug delivery device placement | Surgical and medical procedures | MedDRA 25.1 | Non-systematic Assessment |
| |
| Arterial haemorrhage | Vascular disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increase | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Blood creatine increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Arthralagia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.1 | Non-systematic Assessment |
|
SIRCCA enrollment from February 2017 (180 planned) was slow and thus enrollment terminated early in October 2019 (89 treated). Follow-up until 29 April 2021 was to ensure ≥18 months of data although the primary endpoint was underpowered. An audit to the clinical database detected issues leading to a low level of confidence in the trustworthiness of the collected data. Pharmacovigilance case reconciliation was thus also confounded. The results posted cannot be relied upon as accurate.
PI must provide a proposed publication to Sponsor >=30 days prior to publication submission for review and comment on the appropriateness of the data analysis and presentation, confidential Information, and rights regarding inventions or other intellectual property. The Sponsor may extend the review period by +30 days. Publication can be delayed by Sponsor to file patent applications but such delay shall not exceed 24 months from the date of such notice to the Investigator.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research Operations | Sirtex | +1-888-474-7839 | info-us@sirtex.com |
| Oct 20, 2023 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Belgium |
|
| United States |
|
| Italy |
|
| United Kingdom |
|
| Australia |
|
| France |
|
| Spain |
|
| Absent |
|
| 1 |
|
| Absent |
|
| Whole |
|
| No |
|
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|
|
|
|
|
|
|
|
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