Comparing two treatments for liver metastases from right-sided colon cancer
FOLFOXIRI Plus Cetuximab Versus FOLFOXIRI Plus Bevacizumab in Conversion Therapy of Right-sided Colon Cancer Liver Metastases
This study is testing which combination of treatments works better for people with liver cancer that started from right-sided colon cancer and can't be surgically removed.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, Cetuximab, Bevacuzumab |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT04832776 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two treatment regimens for patients with liver metastases from right-sided colon cancer. Participants will receive either FOLFOXIRI combined with Cetuximab or FOLFOXIRI combined with Bevacizumab as part of their conversion therapy. The study focuses on patients with initially unresectable liver metastases who have not received systemic therapy or have had limited prior treatment. The goal is to determine which combination provides better outcomes for patients.
Who should consider this trial
Good fit: Ideal candidates include patients with RAS wild type colorectal carcinoma and initially unresectable liver metastases who have a good performance status.
Not a fit: Patients with significant comorbidities, such as uncontrolled hypertension or central nervous system metastases, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with liver metastases from right-sided colon cancer.
How similar studies have performed: Other studies have explored similar treatment combinations, but this specific comparison is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ECOG perfomance 0-1 * pathologically confirmed colorectal carcinoma, with RAS wild type * inital unresectable liver metastases discussed by MDT * prior no systemical therapy or exceed 6 months after the adjuvant chemotherapy of primary tumor surgery. * without extraheptic metastatic lesions, except for locally controlled lung metastases (RFA or SBRT) * adequate blood, liver and renal function * expected survival longer than 6 months Exclusion Criteria: * with bleeding risk * interestinal obstruction or disease * uncontrolled hypertension and severe heart disease * previous severe thrombotic events * central nervous system metastases * accompanied with other malignant tumor
Where this trial is running
Shanghai, Shanghai
- Department of Colorectal Surgery Fudan University Shanghai Cancer Center — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Wen Zhang — Fudan University
- Study coordinator: Wenhua Li
- Email: whliiris@hotmail.com
- Phone: 13817922257
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.