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

ConditionColorectal Cancer Metastatic to Liver

Trial statusNot yet recruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Arm A
Drug
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
Drug
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

Treatment groups

102 Participants

are divided into 2 treatment groups

Group A: Arm A ( QL1706 Combined with mFOLFOX6 and Cetuximab )Experimental treatment 1 intervention

Group B: Arm B ( QL1706 Combined with FOLFOXIRI and Bevacizumab )Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

18-month Progression-Free Survival (PFS) rate in phase II

18-month PFS rate is defined as the proportion of participants who are alive and progression free at 18 months from start of study treatment. Assessed according to RECIST v1.1 by investigator.

Time frame