A Single-arm, Single-center, Phase II Clinical Study of Aipalolitovorelizumab (QL1706) Combined With Bevacizumab and Chemotherapy (FOLFOXIRI) as First-line Treatment for MSS/pMMR Metastatic Colorectal Cancer With BRAF V600E Mutation

• Status: NOT_YET_RECRUITING
• Trial end date: 2027-12-01

Summary

This is an open-label, single-arm, single-center phase II clinical study, aiming to investigate the safety and efficacy of Aipalolitovorelizumab (QL1706) combined with bevacizumab plus standard chemotherapy regimen as first-line treatment for patients with MSS/pMMR metastatic colorectal cancer harboring BRAF V600E mutation.

Patients will receive intravenous administration of Aipalolitovorelizumab (QL1706) injection + bevacizumab + oxaliplatin/irinotecan/fluorouracil/calcium folinate, along with oral capecitabine. After completing the corresponding treatment cycles, patients will enter the maintenance treatment phase as determined by the researcher. In the maintenance treatment phase, a 3-week treatment regimen of Aipalolitovorelizumab (QL1706) injection combined with bevacizumab and capecitabine will be adopted, with the administration method and dosage remaining unchanged.

The primary endpoint of this study is objective response rate (ORR); the secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety.

• Phase: PHASE2

Details

• Lead Sponsor: Yanqiao Zhang
• Treatments: Bevacizumab; Capecitabine; Irinotecan; Oxaliplatin; XELOX