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NOT YET RECRUITING
NCT07515963
PHASE2

FULIRI Plus Targeted Therapy for First-line Conversion Therapy of Colorectal Cancer Liver Metastases.

Sponsor: Zhongnan Hospital

View on ClinicalTrials.gov

Summary

This study is a single-center, prospective, randomized, single-arm phase II clinical trial designed to evaluate the safety and efficacy of FULIRI chemotherapy regimen combined with targeted therapy (bevacizumab/cetuximab) as first-line conversion therapy for colorectal cancer with liver metastases. Eligible patients with colorectal cancer and liver metastases, after signing informed consent, received FULIRI chemotherapy combined with bevacizumab/cetuximab targeted therapy. Efficacy was assessed after every four treatment cycles, followed by multidisciplinary team (MDT) discussion regarding potential surgical resection, ablation, or stereotactic radiotherapy. The primary endpoint was the objective response rate (ORR), and secondary endpoints included: disease control rate (DCR), R0 resection rate of liver metastases, progression-free survival (PFS), 3-year/5-year survival rates, and the incidence of acute toxicities of any grade and grades 3/4.

Official title: A Phase II Clinical Study of FULIRI Regimen Chemotherapy Combined With Targeted Therapy for First-line Conversion Treatment of Colorectal Cancer Liver Metastases.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-06-01

Completion Date

2028-02-01

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

DRUG

FULIRI combination targeted therapy

Chemotherapy regimen FULIRI: Irinotecan liposome 70 mg/m2; leucovorin CF 400 mg/m2, d1, iv drop; 5-FU 400 mg/m2, d1, iv drop; 5-FU 2400 mg/m2, d1, CIV 46-48h; repeated every 2 weeks. Combined targeted therapy: Based on tumor gene analysis results, investigators may choose to combine bevacizumab (5 mg/kg, iv drop, d1) or cetuximab (500 mg/m2, iv drop, d1), repeated every 2 weeks.

Locations (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China