FOLFOXIRI Plus Cetuximab Versus FOLFOXIRI Plus Bevacizumab in Conversion Therapy of Right-sided Colon Cancer Liver Metastases

Fudan University

Status and phase: Enrolling; Phase 2

Conditions: Liver Metastasis Colon Cancer

Treatments: Drug: Cetuximab; Drug: FOLFOXIRI; Drug: Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04832776

Cetu-Bev-FOLFOXIRI

Details and patient eligibility

About

To compare the efficacy of FOLFOXIRI plus Cetuximab and FOLFOXIRI plus Bevacuzumab in the conversion therapy of right-sided colon cancer liver metastases

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

160 participants in 2 patient groups

FOLFOXIRI+C225

Experimental group

Treatment:

Drug: FOLFOXIRI

Drug: Cetuximab

FOLFOXIRI+BEV

Active Comparator group

Treatment:

Drug: FOLFOXIRI

Drug: Bevacizumab