FOLFOXIRI Plus Cetuximab Versus FOLFOXIRI Plus Bevacizumab in Conversion Therapy of Right-sided Colon Cancer Liver Metastases
Phase 2
Recruiting
- Conditions
- Liver Metastasis Colon Cancer
- Interventions
- Registration Number
- NCT04832776
- Lead Sponsor
- Fudan University
- Brief Summary
To compare the efficacy of FOLFOXIRI plus Cetuximab and FOLFOXIRI plus Bevacuzumab in the conversion therapy of right-sided colon cancer liver metastases
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FOLFOXIRI+BEV FOLFOXIRI - FOLFOXIRI+C225 Cetuximab - FOLFOXIRI+C225 FOLFOXIRI - FOLFOXIRI+BEV Bevacizumab -
- Primary Outcome Measures
Name Time Method ORR up to 8 weeks objective response rate
- Secondary Outcome Measures
Name Time Method OS up to 6 months overal survival
R0 resection rate of liver metastases up to 8 weeks R0 resection rate of liver metastases
NED rate up to 8 weeks percentage of patients who reach NED
PFS up to 8 weeks progression free survival
Trial Locations
- Locations (1)
Department of Colorectal Surgery Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China