Bevacizumab with a modified FOLFOXIRI chemotherapy regimen for first-line treatment of 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
This test will see if adding bevacizumab to a lower-intensity FOLFOXIRI chemotherapy regimen works better than bevacizumab with mFOLFOX6 as first treatment for patients in China with unresectable metastatic colorectal cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 528 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | bevacizumab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04230187 on ClinicalTrials.gov |
What this trial studies
This is a randomized, multicenter phase III trial comparing mFOLFOXIRI plus bevacizumab versus mFOLFOX6 plus bevacizumab as first-line therapy for patients with unresectable metastatic colorectal adenocarcinoma. The trial uses a modified triplet chemotherapy dose intended to reduce toxicities seen in Asian patients while preserving efficacy. Key outcomes include progression-free survival, overall survival, objective response rate, disease control rate, surgical resection rate, safety, and health-related quality of life. The lead site is the Gastrointestinal Hospital of Sun Yat-sen University in Guangzhou, with enrollment targeted to eligible patients who can attend participating centers in China.
Who should consider this trial
Good fit: Adults with histologically confirmed metastatic colorectal adenocarcinoma, ECOG performance status 0–1, adequate organ function, and measurable or non-measurable disease who meet prior treatment timing criteria are ideal candidates.
Not a fit: Patients with non-adenocarcinoma histologies, poor performance status (ECOG >1), significant organ dysfunction, or contraindications to the study drugs are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the regimen could improve disease control and survival while reducing treatment-related toxicity for Chinese patients with metastatic colorectal cancer.
How similar studies have performed: Previous European and North American trials of FOLFOXIRI plus bevacizumab have shown improved response and survival but with high toxicity, and this trial adapts the regimen to reduce adverse events in Asian patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded. Subjects with metastatic colorectal cancer(CRC) (Stage IV). Subjects treated with oxaliplatin in an adjuvant setting should have progressed during or within 12 months of completion of adjuvant therapy. Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be allowed into the study. Metastatic CRC subjects must have measurable or non measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol. Exclusion Criteria: \- Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization. Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment. Heart failure grade III/IV (NYHA-classification). Unresolved toxicity higher than CTCAE v.4.0 Grade 1 attributed to any prior therapy/procedure. Subjects with known allergy to the study drugs or to any of its excipients. Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study. Breast- feeding or pregnant women Lack of effective contraception.
Where this trial is running
Guangzhou, Guangdong
- Gastrointestinal Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Yanhong Deng, M.D. — Sixth Affiliated Hospital, Sun Yat-sen University
- Study coordinator: Yanhong Deng, M.D.
- Email: 13925106525@163.com
- Phone: 86-13925106525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.