This study is a prospective, single-arm, multicenter exploratory clinical study aimed at evaluating the efficacy and safety of iparomlimab and tuvonralimab combined with bevacizumab and alternating triweekly CAPOX/mCAPIRI regimen as first-line treatment for unresectable advanced colorectal cancer. The study plans to enroll 70 patients with unresectable advanced metastatic colorectal cancer. After evaluation and confirmation of meeting enrollment criteria, patients will receive treatment with iparomlimab and tuvonralimab combined with bevacizumab and alternating triweekly CAPOX/mCAPIRI regimen. The primary endpoint of the study is ORR, and secondary endpoints include PFS, DoR, OS, and safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Induction Phase: Iparomlimab and tuvonralimab (5 mg/kg, Q3W, D1) + bevacizumab (7.5 mg/kg, Q3W, D1) + CAPOX regimen (oxaliplatin 130 mg/m², Q3W, D1; capecitabine 1,000 mg/m², BID, D1-14, Q3W) / mCAPIRI (irinotecan 180 mg/m², Q3W, D1; capecitabine 800 mg/m², BID, D1-14, Q3W) alternating every 42 days, assessed every 6 weeks, for a maximum of 6 cycles. Maintenance Phase: Iparomlimab and tuvonralimab 5 mg/kg, Q3W, D1 + bevacizumab 7.5 mg/kg, Q3W, D1 + capecitabine 800-1,000 mg/m², BID, D1, Q3W. Patients with CR/PR/NED or SD are allowed to receive maintenance therapy until disease progression or intolerable toxicity.
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Investigator-assessed Objective Response Rate(ORR)
CR+PR
Time frame: From enrollment to the end of treatment at 18 months
Investigator-assessed Progression-Free Survival(PFS)
The time from the start of treatment in cancer patients to the observation of disease progression or death from any cause
Time frame: From enrollment to the end of treatment at 18 months
Investigator-assessed Duration of Response(DoR)
The time from the first assessment of complete response or partial response to the first assessment of tumor progression or death from any cause
Time frame: From enrollment to the end of treatment at 18 months
Overall Survival(OS)
Time from enrollment to death from any cause
Time frame: From enrollment to the end of treatment at 36 months
AE
safety
Time frame: From enrollment to the end of treatment at 12 weeks
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