Efficacy and Safety of FOLFOX+Cetuximab vs. FOLFOXIRI+Bevacizumab Both With QL1706 in First-Line Treatment of Left-Sided mCRC

Sponsor
Fujian Cancer Hospital
Study ID
NCT07070713
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Immunotherapy
  • Metastatic Colorectal Cancer With Left-sided Primary Tumor

Eligibility Criteria

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

Interventions

  • FOLFOXIRI + QL1706 + Bevacizumab — DRUG
    FOLFOXIRI(Irinotecan 165mg/m², iv, d1; Oxaliplatin 85mg/m², iv, d1; (Levo) Folinic Acid (200) 400mg/m², iv, d1; total 5-FU 2400mg/m², iv gtt (continuous for 48h), d1) + QL1706 (5mg/kg, i.v., Q3W) + Bevacizumab (5mg/kg, i.v., Q2W)
  • FOLFOX+QL1706+Cetuximab — DRUG
    FOLFOX (Oxaliplatin 85mg/m², iv gtt (for 2h), d1; (Levo) Folinic Acid (200) 400mg/m², iv gtt (for 2h), d1; 5-FU 400mg/m², iv, followed by 2400mg/m², iv gtt (continuous for 46-48h), d1) + QL1706 (5mg/kg, i.v., Q3W) + Cetuximab (500mg/m², i.v., Q2W).

Study Details

This is a two-arm, randomized phase II clinical study. It is planned to enroll 44 patients with primary left-sided, RAS and BRAF wild-type metastatic colorectal cancer. After signing the informed consent, eligible subjects will be screened to enter the clinical study and assigned to two treatment groups using simple randomization and allocation concealment methods. The treatment plans for the two groups are as follows: Group A: FOLFOXIRI (Irinotecan 165mg/m², iv, d1; Oxaliplatin 85mg/m², iv, d1; (Levo) Folinic Acid (200) 400mg/m², iv, d1; total 5-FU 2400mg/m², iv gtt (continuous for 48h), d1) + Bevacizumab (5mg/kg, i.v, Q2W) Group B: FOLFOX (Oxaliplatin 85mg/m², iv gtt (for 2h), d1; (Levo) Folinic Acid (200) 400mg/m², iv gtt (for 2h), d1; 5-FU 400mg/m², iv, followed by 2400mg/m², iv gtt (continuous for 46-48h), d1) + Cetuximab (500mg/m², i.v, Q2W) Both groups A and B will repeat the treatment every 2 weeks, for a maximum of 9 cycles. Then, the attending physician will decide whether to conduct maintenance treatment (Capecitabine or 5FU/LV with or without Bevacizumab is recommended). Both groups A and B will be combined with QL1706 (5mg/kg, i.v, Q3W) for a maximum of 52 weeks. Medication will continue until the researcher judges that there is no longer clinical benefit (the researcher makes a comprehensive judgment based on RECIST v1.1 imaging evaluation and clinical status, etc.), intolerable toxicity occurs, the subject withdraws informed consent, or other criteria for terminating treatment in the protocol are met, whichever comes first.

Key Dates

First listed
Jul 17, 2025
Start date
Jul 30, 2025
Status verified
Jul 2025
Primary completion
Feb 28, 2028
Completion
Aug 30, 2028

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A group：FOLFOXIRI + QL1706 + Bevacizumab
    FOLFOXIRI (irinotecan 165 mg/m², iv, d1; oxaliplatin 85 mg/m², iv, d1; (levo)leucovorin 400 mg/m², iv, d1; 5-FU total dose 2400 mg/m², iv infusion (continuous for 48 hours), d1) +QL1706 (5mg/kg, i.v, Q3W) + bevacizumab (5 mg/kg, i.v., every 2 weeks).
  • Active Comparator: B group：FOLFOX + QL1706 + Cetuximab
    FOLFOX (oxaliplatin 85 mg/m², intravenous infusion (2 hours), day 1; (levo)leucovorin (200) 400 mg/m², intravenous infusion (2 hours), day 1; 5-FU 400 mg/m², intravenous injection, followed by 2400 mg/m², intravenous infusion (continuous for 46-48 hours), day 1) +QL1706 (5mg/kg, i.v, Q3W) + cetuximab (500 mg/m², intravenous infusion, every 2 weeks).

Primary Outcome Measure

Objective Response Rate [ Time Frame: 18 weeks ]

Central Contacts

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