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HepaSphereâ„¢ Microspheres loaded with irinotecan received CE mark for the indication of use in embolization of metastatic colorectal cancer (mCRC) to the liver in 2015.
The purpose of this registry is to demonstrate the safety and efficacy of HepaSphere Microspheres loaded with irinotecan for the treatment of colorectal liver metastasis and add to the understanding of the use and value of this treatment in 'real life' usage conditions.
This prospective, post-market study was designed to evaluate the median overall survival (MOS) of subjects with metastatic colorectal cancer (mCRC) to the liver treated with HepaSphere Microspheres loaded with the chemotherapeutic agent irinotecan. This treatment process is referred to as transarterial chemoembolization (TACE).
Subjects with confirmed colorectal cancer liver metastases that were ineligible for surgical hepatic tumor resection and that had not undergone prior TACE for this indication were considered for study participation. Patients that met eligibility criteria, wanted to participate in the study, and signed the informed consent form (ICF) made up the study subject population. All study subjects were in one cohort and were not blinded to treatment.
Per protocol, all subjects completed a baseline visit to collect medical history information, lab assessments, and have a baseline MRI. Following this baseline visit subjects were to have two TACE cycles (i.e., TACE Cycle 1, TACE Cycle 2), with TACE Cycle 2 occurring within 2-4 weeks following TACE Cycle 1. A TACE cycle is defined as one TACE procedure for subjects with unilobar disease or two TACE procedures for subjects with bilobar disease (i.e., one for each lobe of the liver). Following completion of TACE Cycle 1 and TACE Cycle 2, additional TACE cycles could be performed at the investigator's discretion for residual or new disease.
When subjects had completed two TACE cycles and were no longer indicated for further TACE cycles (at the investigator's discretion), they entered follow-up. The study ended and analysis began when all enrolled subjects had (1) completed two-year (24 months) follow-up from the date of TACE Cycle 1, (2) been deemed lost to follow up, or (3) died, whichever occurred first.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HepaSphere Microspheres | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Median overall survival of subjects treated with HepaSphere Microspheres loaded with irinotecan. Analysis will be performed when all subjects enrolled have been followed for survival for two years (24 months), are considered lost to follow up, or have died, whichever comes first | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Determined by the Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) when all subjects enrolled have been followed for survival for 2 years (from date of 1st TACE), are considered lost to follow up, or have died, whichever comes first. Per mRECIST (target lesions assessed by MRI): Complete Response (CR), at least >=30% decrease in the sum of diameters of all viable target lesions, Partial Response (PR), at least a >=30% decrease in the sum of diameters of all viable target lesions, Stable Disease (SD), any cases that do not qualify for either partial response or progressive disease, Progressive Disease (PD), An increase of at least 20% in the sum of the diameters of or viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since started. Overall Response (OR) = CR + PR. ORR is calculated as= (no. of patients with CR + the no. of patients with PR) / N. (N= No of participants analyzed) |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with unresectable metastatic colorectal cancer with metastases to the liver.
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| Name | Affiliation | Role |
|---|---|---|
| Katerina Malagari, MD | Evgenidio Hospital/ATTIKO Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Hospital Georges Pompidou | Paris | 75015 | France | |||
| Evgenidio Hospital/ATTIKO Hospital |
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Study enrollment began in September 2016 and ended in May 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Metastatic Colorectal Cancer to the Liver | This was a non-randomized, single arm, prospective study that included all enrolled study participants that met the inclusion criteria, did not meet the exclusion criteria, and provided written informed consent. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrolled and Completion of TACE Cycle 1 |
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| Completion of TACE Cycle 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Metastatic Colorectal Cancer to the Liver | This was a non-randomized, single arm, prospective study that included all enrolled study participants that met the inclusion criteria, did not meet the exclusion criteria, and provided written informed consent. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Overall Survival | Median overall survival of subjects treated with HepaSphere Microspheres loaded with irinotecan. Analysis will be performed when all subjects enrolled have been followed for survival for two years (24 months), are considered lost to follow up, or have died, whichever comes first | All enrolled subjects received one or more TACE Cycles and therefore were included in the calculation of the primary endpoint, Median Overall Survival. | Posted | Median | 95% Confidence Interval | months | 24 months |
|
Treatment related adverse events (AEs) were collected throughout the duration of this study. Follow-up ranged from 30 to 1315 days.
Only treatment related adverse events (AEs) were collected throughout the duration of this study. Treatment related AEs were defined as AEs that occurred on the day of or any day following a subject's first TACE procedure and determined to be treatment related by the investigator.
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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 | Patients With Metastatic Colorectal Cancer to the Liver | This was a non-randomized, single arm, prospective study that included all enrolled study participants that met the inclusion criteria, did not meet the exclusion criteria, and provided written informed consent. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tumor rupture | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vicky Brunk RN, Vice President, Medical Affairs, Merit Medical | Merit Medical Systems, Inc. | +1 (717) 873-3309 | vicky.brunk@merit.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 21, 2021 | Dec 17, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 8, 2021 | Dec 17, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| 24 months |
| Best Tumor Response | Per the Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) for target lesions and assessed by MRI: Complete Response (CR), at least > =30% decrease in the sum of diameters of all viable ( enhancement in the arterial phase) target lesions, Partial Response (PR), at least a >=30% decrease in the sum of diameters of all viable (enhancement in the arterial phase) target lesions, Stable Disease (SD), any cases that do not qualify for either partial response or progressive disease, Progressive Disease (PD), An increase of at least 20% in the sum of the diameters of or viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since started. Best Tumor Response (BTR) was assessed during the period of time between TACE Cycle 1 and the last post-TACE MRI or CT. BTR will be presented as the number of subjects within each response category and percentage of evaluated subjects. | 24 months |
| Liver Progression-free Survival | Median liver progression-free survival will be calculated as the time (in months) between the first TACE procedure to the date on which progression of the subject's liver metastases was documented or the date of death (from any cause). Per the Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) for target lesions and assessed by MRI, Progressive Disease (PD) is defined as an increase of at least 20% in the sum of the diameters of or viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since started. | 24 months |
| Time to Progression | Time to Progression (TTP) was defined as the length of time between TACE Cycle 1 and disease progression (as determined by MRI or CT imaging) of both hepatic and extrahepatic disease. The date of the first study TACE was time zero. | 24 months |
| Athens |
| 11528 |
| Greece |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Baseline Disease Status: Tumor Location | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Objective Response Rate (ORR) | Determined by the Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) when all subjects enrolled have been followed for survival for 2 years (from date of 1st TACE), are considered lost to follow up, or have died, whichever comes first. Per mRECIST (target lesions assessed by MRI): Complete Response (CR), at least >=30% decrease in the sum of diameters of all viable target lesions, Partial Response (PR), at least a >=30% decrease in the sum of diameters of all viable target lesions, Stable Disease (SD), any cases that do not qualify for either partial response or progressive disease, Progressive Disease (PD), An increase of at least 20% in the sum of the diameters of or viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since started. Overall Response (OR) = CR + PR. ORR is calculated as= (no. of patients with CR + the no. of patients with PR) / N. (N= No of participants analyzed) | Only subjects with complete imaging could be analyzed. Eighty three of the subjects had imaging and were evaluated using mRECIST criteria to calculate the objective response rate (ORR). | Posted | Count of Participants | Participants | No | 24 months |
|
|
|
| Secondary | Best Tumor Response | Per the Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) for target lesions and assessed by MRI: Complete Response (CR), at least > =30% decrease in the sum of diameters of all viable ( enhancement in the arterial phase) target lesions, Partial Response (PR), at least a >=30% decrease in the sum of diameters of all viable (enhancement in the arterial phase) target lesions, Stable Disease (SD), any cases that do not qualify for either partial response or progressive disease, Progressive Disease (PD), An increase of at least 20% in the sum of the diameters of or viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since started. Best Tumor Response (BTR) was assessed during the period of time between TACE Cycle 1 and the last post-TACE MRI or CT. BTR will be presented as the number of subjects within each response category and percentage of evaluated subjects. | Only subjects with complete imaging could be analyzed. Eighty three of the subjects had imaging and were evaluated using mRECIST criteria. | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Secondary | Liver Progression-free Survival | Median liver progression-free survival will be calculated as the time (in months) between the first TACE procedure to the date on which progression of the subject's liver metastases was documented or the date of death (from any cause). Per the Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) for target lesions and assessed by MRI, Progressive Disease (PD) is defined as an increase of at least 20% in the sum of the diameters of or viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since started. | Only 17 subjects had data available to calculate progression free survival (definition: a lack of tumor progression in the liver as determined by mRECIST criteria). | Posted | Median | 95% Confidence Interval | months | 24 months |
|
|
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| Secondary | Time to Progression | Time to Progression (TTP) was defined as the length of time between TACE Cycle 1 and disease progression (as determined by MRI or CT imaging) of both hepatic and extrahepatic disease. The date of the first study TACE was time zero. | A total of 87 subjects had disease progression after one or more study TACE procedures, 66 with hepatic progression and 21 with extrahepatic progression. | Posted | Median | 95% Confidence Interval | Months | 24 months |
|
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|
| 79 |
| 105 |
| 1 |
| 105 |
| 97 |
| 105 |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Abscess | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Liver abscess | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 17.0 | Systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA 17.0 | Systematic Assessment |
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| Transaminases increased | Investigations | MedDRA 17.0 | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA 17.0 | Systematic Assessment |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| Progressive Disease (PD) |
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