Clinical Trial

FOLFIRI Plus Bevacizuamb and QL1706 in Second-Line Treatment for mCRC

Study acronym: FIRBIT
Not Yet Recruiting Phase 3
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Summary
Thsi study is a randomised, parallel-controlled phase II/III trial evaluating FOLFIRI plus bevacizumab with or without QL1706 as second-line therapy for metastatic colorectal cancer. The primary endpoint is PFS. Secondary endpoint includes overall survival, objective response rate, safety profiles, immune-related adverse events, and patient quality of life. Exploratory analyses focus on dynamic shifts in tumour immune microenvironment and biomarkers, aiming to identify predictive signatures for therapeutic efficacy and immune toxicities.
Trial Details
NCT Number NCT07729605
Lead Sponsor Sun Yat-sen University
Conditions Colorectal Cancer Metastatic, Microsatellite Stable (MSS) Colorectal Cancer (CRC)
Enrollment 270 participants
Start Date 2026-07-30
Primary Completion 2028-12-30 (estimated)
Study Completion 2029-07-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-27