Treatment for colorectal cancer patients with liver metastases that can't be surgically removed
Conversion Therapy of RAS/BRAF Wild-Type Colorectal Cancer Patients With Initially Unresectable Liver Metastases: mFOLFOXIRI Plus Cetuximab Versus mFOLFOXIRI Plus Bevacizumab
This study is testing two different treatment combinations to see which one helps colorectal cancer patients with liver tumors that can’t be removed by surgery live longer and possibly make their tumors operable.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 508 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, cetuximab, bevacizumab |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT04687631 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of two different treatment regimens for patients with RAS/BRAF wild-type colorectal cancer and initially unresectable liver metastases. Participants will be randomly assigned to receive either modified FOLFOXIRI combined with cetuximab or modified FOLFOXIRI combined with bevacizumab. The study aims to determine which combination improves the chances of making liver metastases resectable and enhances overall survival. Patients will be monitored through imaging assessments every eight weeks to evaluate their response to treatment.
Who should consider this trial
Good fit: Ideal candidates are adults with RAS/BRAF wild-type colorectal adenocarcinoma and initially unresectable liver metastases.
Not a fit: Patients with extrahepatic metastases or those who have previously received targeted therapy or chemotherapy for their liver metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes and increase the chances of surgical resection for patients with liver metastases from colorectal cancer.
How similar studies have performed: Previous studies have shown promising results with similar treatment approaches, but this specific comparison of cetuximab versus bevacizumab in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The primary tumor was confirmed by histology as colorectal adenocarcinoma 2. Initially unresectable liver metastases suggested by MDT 3. RAS/BRAF gene wild-type states 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5. Life expectancy ≥ 3 months 6. Good hematological function: neutrophil ≥ 1.5x109 / L and platelet count ≥ 100x109 / L; HB ≥ 9g / dl (within one week before randomization) 7. Normal liver and kidney function: serum bilirubin ≤ 1.5x normal upper limit (ULN), alkaline phosphatase ≤ 5x ULN, serum transaminase (AST or ALT) ≤ 5x ULN (within one week before randomization); 8. Sign the written informed consent to participate in the experiment Exclusion Criteria: 1. Patients with liver metastases from colorectal cancer who have previously received targeted therapy, chemotherapy, radiotherapy or interventional therapy 2. Known or suspected extrahepatic metastasis 3. Patients with known hypersensitivity to any component of the study treatment 4. Clinical related coronary heart disease or history of myocardial infarction in the last 12 months or left ventricular ejection fraction below normal range 5. Acute or subacute intestinal obstruction 6. Pregnancy (no pregnancy confirmed by serum / urine β - hCG) or breastfeeding. 7. Other malignant tumors within 5 years, except for those with skin basal cell carcinoma or cervical cancer 8. Known drug / alcohol abuse 9. No legal capacity or limited legal capacity
Where this trial is running
Shanghai, Shanghai Municipality
- Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jianmin Xu, MD, Ph.D. — Fudan University
- Study coordinator: Jianmin Xu, MD, Ph.D.
- Email: xujmin@aliyun.com
- Phone: 86-21-64041990
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.