The QL1706 Combined With Chemotherapy and Either Cetuximab or Bevacizumab in Potentially Resectable Colorectal Cancer Patients With Liver Metastases
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.
Timeline
- Start
- 2026-09
- Primary completion
- 2029-05-27
- Completion
- 2029-11-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Arm A | Unknown | 400 mg/m2 | Intravenous |
| Subject | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Cetuximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 150 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | QL1706 | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |