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.

NCT04003792 | Unknown Phase 2

• 1 other identifier: 0275-19-RMC
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Metastasis Colon Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Study Arms (1)

single arm prospective trial

EXPERIMENTAL

Drug: oxaliplatin; Drug: FOLFIRI Protocol; Drug: Bevacizumab

Interventions

oxaliplatin DRUG

intra-arterial oxaliplatin administration

single arm prospective trial

FOLFIRI Protocol DRUG

systemic FOLFIRI chemotherapy

single arm prospective trial

Bevacizumab DRUG

systemic bevacuzimab therapy

single arm prospective trial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel

RECRUITING

MeSH Terms

Interventions

Oxaliplatin; IFL protocol; Bevacizumab

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Eran Sadot, MD

CONTACT

+972-3-9376201; eransadot@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hepatopancreatobiliary service, Principal Investigator

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 1, 2019
• Study Start: January 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: October 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)