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Not Yet Recruiting NCT07863869

The QL1706 Combined With Chemotherapy and Either Cetuximab or Bevacizumab in Potentially Resectable Colorectal Cancer Patients With Liver Metastases

Conditions: Colorectal Cancer Metastatic to Liver

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 102
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.

Eligibility Criteria

Inclusion Criteria: * Has signed a written informed consent form and voluntarily participates in this study; * Age: 18-75 years old, regardless of gender; * Histologically or cytologically confirmed colorectal adenocarcinoma with liver metastases, initially unresectable but potentially resectable as assessed by a multidisciplinary team (MDT), without other definite extrahepatic distant metastases; * No prior systemic treatment; * Known RAS and BRAF status; * No contraindications to liver surgery; * At least one measurable lesion according to RECIST 1.1; * ECOG performance status: 0-1; * Expected survival time \> 12 weeks; * Sufficient organ and bone marrow function. Exclusion Criteria: * Active autoimmune diseases requiring systemic treatment occurring within 2 years before enrollment. * Previous receipt of immune checkpoint inhibitors, including: anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, etc. * Previous receipt of targeted drugs targeting epidermal growth factor receptor (EGFR), vascular endothelial growth factor (VEGF), or their receptors (VEGFR), including bevacizumab, cetuximab, panitumumab, aflibercept, regorafenib, anlotinib, etc. * Definite extrahepatic distant metastatic lesions. * Unresectable primary tumor. * HIV infection, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation (except corneal transplantation). * Previous or concurrent other malignant tumors within 5 years; * Accompanying pleural effusion, pericardial effusion, or ascites that is uncontrollable and requires drainage. * Known active pulmonary tuberculosis, radiation pneumonitis, drug-induced pneumonia, or other diseases, symptoms, or signs causing severe impairment of lung function.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07863869). StuddyBuddy aggregates publicly available trial information.