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The QL1706 Combined With Chemotherapy and Either Cetuximab or Bevacizumab in Potentially Resectable Colorectal Cancer Patients With Liver Metastases
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Summary
The goal of this clinical trial is to learn if QL1706 (Iparomlimab/ Tuvonralimab)+ chemotherapy+ cetuximab/bevacizumab works to treat potentially resectable colorectal cancer patients with liver metastases in adults. It will also learn about the safety of this therapeutic regimen. The main questions it aims to answer are: Does QL1706+ Chemotherapy+ Cetuximab/Bevacizumab improve the 18-month progression free survival (PFS) rate of participants? The study plans to enroll 90-102 patients, who will be divided into 2 arms based on the primary tumor location and genetic status. Arm A: Patients with primary tumors located in the left colorectum and RAS ( Rat Sarcoma Virus ) and BRAF ( V-raf Murine Sarcoma Viral Oncogene Homolog B ) wild-type. Arm B: Patients with primary tumors located in the right colorectum and/or RAS or BRAF mutant The study consists of two phases: phase Ib ( safety run-in phase ) and phase II.
Official title: A Phase ⅠB/Ⅱ Study of QL1706 Combined With Chemotherapy and Either Cetuximab or Bevacizumab in Potentially Resectable Colorectal Cancer Patients With Liver Metastases
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
102
Start Date
2026-09
Completion Date
2029-11-27
Last Updated
2026-10-19
Healthy Volunteers
No
Conditions
Interventions
Arm A
QL1706 3mg/kg, IV, D1, Q2W, for a maximum of 2 years. mFOLFOX6 : Oxaliplatin 85 mg/m², IV, D1, Q2W, for a maximum of 12 cycles. LV 400mg/m², IV, D1, Q2W, for a maximum of 2 years. 5-FU 400mg/m², IV, D1; followed by a continuous intravenous infusion of 1200mg/(m²•d) for 2 days (total dose 2400mg/m², infusion duration 46-48 hours), Q2W, for a maximum of 2 years. Cetuximab 500mg/m², IV, D1, Q2W, for a maximum of 2 years.
Arm B
QL1706 3mg/kg, IV, D1, Q2W, for a maximum of 2 years FOLFOXIRI : Irinotecan 150mg/m², IV, D1, Q2W, for a maximum of 12 cycles Oxaliplatin 85mg/m², IV, D1, Q2W, for a maximum of 12 cycles LV 400mg/m², IV, D1, Q2W, for a maximum of 2 years 5-FU (total dose: 2400mg/m²) via continuous intravenous infusion for 48 hours, D1, Q2W, for a maximum of 2 years Bevacizumab 5mg/kg, IV, D1, Q2W, for a maximum of 2 years