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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
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 (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).
Fujian Cancer Hospital
Fuzhou, Fujian, China
Objective Response Rate
The percentage of participants in the analysis dataset who achieve a best overall response of Complete Response (CR) or Partial Response (PR) from the start of treatment until disease progression or withdrawal from the study.
Time frame: 18 weeks
Duration of Response
The time from the first assessment of Complete Response (CR) or Partial Response (PR) until the first assessment of Progressive Disease (PD) or death from any cause.
Time frame: 52 weeks
Disease Control Rate
The proportion of patients whose tumors have shrunk or remained stable for a certain period of time, including cases of Complete Response (CR), Partial Response (PR), and Stable Disease (SD).
Time frame: 18 weeks
Progression Free Survival
The time from the day of enrollment until the first occurrence of disease progression (PD) or death due to any cause.
Time frame: 52 weeks
Overall Survival
It refers to the time from the date of enrollment to the date of death due to any cause.
Time frame: 52 weeks
Incidence of Adverse Events
fatigue, nausea/vomiting, abdominal pain and diarrhea, stomatitis, hepatic dysfunction, myelosuppression, etc.
Time frame: 30 days after the end of study
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