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.
1. Age 18-75 years;
2. Patients with histologically or cytologically confirmed unresectable, advanced colorectal cancer;
3. No prior systemic treatment;
4. ECOG PS score ≤2;
1. Prior hypersensitivity to any of the study drugs;
2. Active or known or suspected autoimmune disease requiring systemic treatment, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring bronchodilator intervention;
3. Presence of non-measurable lesions (e.g., pleural effusion/ascites, carcinomatous lymphangitis, diffuse liver involvement, bone metastases);
4. Pregnant or lactating women;
Single group
Iparomlimab and tuvonralimab
DrugInduction 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.
Investigator-assessed Objective Response Rate（ORR）
CR+PR
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
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
Overall Survival（OS）
Time from enrollment to death from any cause
AE
safety
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