NCT07229846

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Yanqiao Zhang · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Aipalolitovorelizumab	Aipalolitovorelizumab (QL1706) Injection: 5 mg/kg, intravenous infusion (ivgtt), d1, Q3W;
DRUG	XELOX + Bevacizumab	Bevacizumab 7.5 mg/kg, intravenous infusion, Day 1; Oxaliplatin 130 mg/㎡, intravenous infusion over 2 hours, Day 1; Capecitabine 1000 mg/㎡, oral administration (po), twice a day (bid), Days 1-14. Repeat every 3 weeks.
DRUG	mFOLFOX + Bevacizumab	Bevacizumab 5 mg/kg, intravenous infusion, Day 1; Oxaliplatin 85 mg/㎡, intravenous infusion over 2 hours, Day 1; Calcium Folinate 400 mg/m², intravenous infusion over 2 hours, Day 1; Fluorouracil 400 mg/m², intravenous bolus, Day 1, followed by 1200 mg/(m²·d) continuous intravenous infusion for 2 days (total dose 2400 mg/m², infusion over 46-48 hours). Repeat every 2 weeks.
DRUG	FOLFOXIRI + Bevacizumab	Bevacizumab 5 mg/kg, intravenous infusion, Day 1; Irinotecan 165 mg/m², intravenous infusion, Day 1; Oxaliplatin 85 mg/m², intravenous infusion, Day 1; Calcium Folinate 400 mg/m², intravenous infusion, Day 1; Fluorouracil with a total dose of 2400-3200 mg/m², continuous intravenous infusion over 48 hours on Day 1. Repeat every 2 weeks.
DRUG	Oxaliplatin + Irinotecan + Capecitabine + Bevacizumab	Bevacizumab 7.5 mg/kg, intravenous infusion, Day 1; Oxaliplatin 130 mg/㎡, intravenous infusion over 2 hours, Day 1; Irinotecan 180 mg/m², intravenous infusion over 30-90 minutes, Day 1; Capecitabine 1000 mg/㎡, oral administration (po), twice a day (bid), Days 1-14. Repeat every 3 weeks.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-02-01
• Completion: 2028-02-01
• First posted: 2025-11-17
• Last updated: 2026-01-08

Locations

1 site across 1 country: China