Back to resultsTreatment With Hepatic Arterial Infusion of Oxaliplatin in Combination With Systemic FOLFIRI Chemotherapy and Bevacuzimab in Patients With Liver-only Colorectal Liver Metastases (CRLM): Conversion to Complete Resection in Patients With Initially Inoperable Liver-only CRLM.
Primary Purpose
Liver Metastasis Colon Cancer
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
oxaliplatin
FOLFIRI Protocol
Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Liver Metastasis Colon Cancer
Eligibility Criteria
Subject Inclusion Criteria:
- Histologically confirmed colorectal adenocarcinoma metastatic to the liver.
- The patient must have inoperable liver metastases as agreed upon by any two hepatobiliary surgeons and the assigned radiologist.
- A patient may have had prior chemotherapy or be previously untreated.
- ECOG PS <2
Subject Exclusion Criteria:
- Prior radiation, hepatic thermo ablation or resection (other than biopsy) to the liver.
- Patient may not have received prior treatment with hepatic artery infusion (HAI).
- Extrahepatic metastases
- Female patients who are pregnant or lactating
Sites / Locations
- Rabin Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single arm prospective trial
Arm Description
Outcomes
Primary Outcome Measures
conversion rate to complete resection in patients with initially inoperable liver-only metastases due to colorectal cancer after treatment with HAI of oxaliplatin with FOLFIRI and bevacuzimab systemic treatment.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04003792
Brief Title
Treatment With Hepatic Arterial Infusion of Oxaliplatin in Combination With Systemic FOLFIRI Chemotherapy and Bevacuzimab in Patients With Liver-only Colorectal Liver Metastases (CRLM): Conversion to Complete Resection in Patients With Initially Inoperable Liver-only CRLM.
Official Title
Treatment With Hepatic Arterial Infusion of Oxaliplatin in Combination With Systemic FOLFIRI Chemotherapy and Bevacuzimab in Patients With Liver-only Colorectal Liver Metastases (CRLM): Conversion to Complete Resection in Patients With Initially Inoperable Liver-only CRLM.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
A few studies have documented that some patients can be down-staged from an initially inoperable state to a potentially resectable state. Five-year survival in initially inoperable patients that ultimately come to a complete resection appears to be similar to patients who are resected at first presentation. The investigators goal is to assess the rate of conversion to complete resection in patients with initially inoperable liver-only metastases due to colorectal cancer after treatment with HAI of oxaliplatin with FOLFIRI and bevacuzimab systemic treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Metastasis Colon Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single arm prospective trial
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Description
intra-arterial oxaliplatin administration
Intervention Type
Drug
Intervention Name(s)
FOLFIRI Protocol
Intervention Description
systemic FOLFIRI chemotherapy
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
systemic bevacuzimab therapy
Primary Outcome Measure Information:
Title
conversion rate to complete resection in patients with initially inoperable liver-only metastases due to colorectal cancer after treatment with HAI of oxaliplatin with FOLFIRI and bevacuzimab systemic treatment.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Subject Inclusion Criteria:
Histologically confirmed colorectal adenocarcinoma metastatic to the liver.
The patient must have inoperable liver metastases as agreed upon by any two hepatobiliary surgeons and the assigned radiologist.
A patient may have had prior chemotherapy or be previously untreated.
ECOG PS <2
Subject Exclusion Criteria:
Prior radiation, hepatic thermo ablation or resection (other than biopsy) to the liver.
Patient may not have received prior treatment with hepatic artery infusion (HAI).
Extrahepatic metastases
Female patients who are pregnant or lactating
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eran Sadot, MD
Phone
+972-3-9376201
Email
eransadot@gmail.com
Facility Information:
Facility Name
Rabin Medical Center
City
Petach Tikva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eran Sadot
Email
eransadot@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment With Hepatic Arterial Infusion of Oxaliplatin in Combination With Systemic FOLFIRI Chemotherapy and Bevacuzimab in Patients With Liver-only Colorectal Liver Metastases (CRLM): Conversion to Complete Resection in Patients With Initially Inoperable Liver-only CRLM.
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