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

Sponsor
Yanqiao Zhang
Study ID
NCT07229846
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Aipalolitovorelizumab — DRUG
    Aipalolitovorelizumab (QL1706) Injection: 5 mg/kg, intravenous infusion (ivgtt), d1, Q3W;
  • XELOX + Bevacizumab — DRUG
    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.
  • mFOLFOX + Bevacizumab — DRUG
    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.
  • FOLFOXIRI + Bevacizumab — DRUG
    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.
  • Oxaliplatin + Irinotecan + Capecitabine + Bevacizumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 28, 2026
Status verified
Jan 2026
Primary completion
Feb 28, 2027
Completion
Feb 29, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single-arm experimental group

Primary Outcome Measure

Objective Response Rate [ Time Frame: 6 months ]

Central Contacts

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