RecruitingPhase 3NCT04781270

mFOLFOXIRI+Bev vs. mFOLFOX6+Bev for RAS Mutant Unresectable Colorectal Liver-limited Metastases

mFOLFOXIRI Plus Bevacizumab Versus mFOLFOX6 Plus Bevacizumab for the First Line Treatment of RAS Mutant Unresectable Colorectal Liver-limited Metastases

Sponsor

Fudan University

Enrollment

308 participants

Start Date

Apr 15, 2021

Study Type

INTERVENTIONAL

Conditions

Colorectal Carcinoma Liver Metastases

Summary

Colorectal cancer patients with initially unresectable liver-only metastases may be cured after downsizing of metastases by conversion therapy. However, the optimal regimen of conversion therapy for RAS mutant patients has not been defined. In this study colorectal cancer patients with initially unresectable liver-only metastases, as prospectively confirmed by a local multidisciplinary team (MDT) according to predefined criteria, will be tested for RAS and BRAF tumor mutation status. Patients with RAS mutant and BRAF wild type will be randomised between modified FOLFOXIRI (mFOLFOXIRI) plus bevacizumab and modified FOLFOX6 (mFOLFOX6) plus bevacizumab. Patient imaging will be reviewed for resectability by MDT, consisting of at least one radiologist and three liver surgeons every assessment. MDT review will be performed prior to randomization as well as during treatment, as described in the protocol.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares two chemotherapy regimens — a more intensive triple-drug combination (mFOLFOXIRI + bevacizumab) versus a standard two-drug combination (mFOLFOX6 + bevacizumab) — in people with colorectal cancer that has spread to the liver only, carries a RAS mutation, and is not currently removable by surgery. The goal is to see if the more intensive approach can shrink tumors enough to make surgery possible. **You may be eligible if...** - You are 18–75 years old with colorectal cancer that has spread to the liver only - Your tumor has a RAS mutation and does not have the BRAF V600E mutation - The liver metastases are not currently removable but the primary tumor is (or has been removed) - You have not yet received chemotherapy for metastatic disease - Your blood counts and organ function are adequate **You may NOT be eligible if...** - Your cancer has spread beyond the liver (e.g., to the lungs or other organs) - You have already received chemotherapy for metastatic disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGmFOLFOXIRI regimen

oxaliplatin 85 mg/m2, irinotecan 165 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1

DRUGmFOLFOX regimen

oxaliplatin 85 mg/m2, and folinic acid 400 mg/m2 followed by bolus 5-fluorouracil 400 mg/m2 and 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1

DRUGBevacizumab

5 mg/kg on day 1