RecruitingPhase 3NCT04230187

Bevacizumab Plus mFOLFOXIRI as First-line Treatment for Patients With Unresectable Metastatic Colorectal Cancer

Bevacizumab Plus mFOLFOXIRI or mFOLFOX-6 as First-line Treatment for Patients With Unresectable Metastatic Colorectal Cancer: a Randomised, Open-label, Phase 3 Trial

Sponsor

Yanhong Deng

Enrollment

528 participants

Start Date

Sep 1, 2020

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer

Summary

The current clinical trials and data on the triplet regimen combined with bevacizumab for first-line treatment of metastatic colorectal cancer were from European and American populations. The triplet regimens recommended by the NCCN and ESMO guidelines using irinotecan and 5-FU at a higher dose intensity cause a high incidence of adverse events in Asian population, and there was no high-quality data on efficacy in Chinese population, both of which have limited the clinical applications of the regimens in China. This study intends to conduct an improved triplet regimen (mFOLFOXIRI) combined with bevacizumab versus mFOLFOX6 combined with bevacizumab as a first-line multicenter, randomized, controlled phase III clinical trial in patients with advanced colorectal cancer. Progression-free survival (PFS), observable response rate (ORR), overall survival (OS), disease control rate (DCR), surgical resection rate, and safety and health-related quality of life (HRQoL) were assessed in the two groups of subjects.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination chemotherapy regimen (bevacizumab plus a combination called mFOLFOXIRI) as a first-line treatment for patients with metastatic colorectal cancer — colon or rectal cancer that has spread to other organs. **You may be eligible if...** - You have a confirmed diagnosis of colorectal cancer (specifically adenocarcinoma) that has spread (Stage IV) - You have not yet received chemotherapy for metastatic disease (though some prior adjuvant chemotherapy may be allowed if it was completed more than 12 months ago) - Your cancer is measurable on imaging scans - Your overall health is reasonably good (ECOG performance status 0 or 1) - Your blood counts, liver, and kidney function meet study requirements **You may NOT be eligible if...** - Your colorectal cancer is not an adenocarcinoma (different cell type) - You had a different primary cancer in the last 5 years - You had a heart attack or unstable chest pain within the last 6 months - You have significant heart failure - You have known allergy to the study drugs 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 plus Bevacizumab

Bevacizumab (5 mg/kg on day 1) plus mFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) for 8 cycles and followed by bevacizumab and fluoropyrimidine based maintence treatment

DRUGmFOLFOX6 Plus Bevacizumab

mFOLFOX6 (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) for 8 cycles and followed by bevacizumab and fluoropyrimidine based maintence treatment