This study is a prospective, single-arm, multicenter exploratory clinical study aimed at evaluating the efficacy and safety of Fruquintinib combined With Serplulimab and chemotherapy as first-line treatment for RAS/BRAF-mutated unresectable advanced colorectal cancer. The study plans to enroll 80 patients with RAS/BRAF-mutated unresectable advanced metastatic colorectal cancer. After evaluation and confirmation of meeting enrollment criteria, patients will receive treatment with Fruquintinib combined With Serplulimab and chemotherapy . The primary endpoint of the study is PFS, and secondary endpoints include ORR, DCR, OS, and safety.
18 to 75 years (inclusive), male or female.
Diagnosis of advanced unresectable or metastatic colorectal cancer.
Confirmed RAS/BRAF mutation by testing.
No prior systemic therapy for unresectable or metastatic colorectal cancer. (Prior adjuvant or neoadjuvant chemotherapy with one regimen is allowed if recurrence occurred ≥6 months after completion of chemotherapy.)
- History of hypersensitivity to any anti-angiogenic targeted agent, any component of monoclonal antibodies, capecitabine, oxaliplatin, or other platinum-based drugs.
Untreated central nervous system (CNS) metastases.
Major surgery or severe trauma within 4 weeks prior to first study drug administration.
Current use of immunosuppressive agents, or systemic or absorbable local hormone therapy for immunosuppressive purposes (dose >10 mg/day prednisone or equivalent), and continued use within 2 weeks before enrollment.
Single group
Serplulimab+Fruquintinib+XELOX
Drugcombination regimen of fruquintinib, serplulimab, and XELOX for 6-8 cycles. The dosing schedule is as follows: Fruquintinib: 3 mg/day, QD, PO, daily for 21 days of each 28-day cycle Serplulimab: 4.5 mg/kg, D1, intravenous infusion, Q3W XELOX ：Oxaliplatin: 130 mg/m², intravenous infusion over 0-2 hours, D1, Q3W Capecitabine: 1000 mg/m², PO, BID, D1-14, Q3W Maintenance therapy administration: After completion of the combination therapy, subjects with a response assessment of CR, PR, or SD, , will enter the maintenance phase: Fruquintinib、Serplulimaband Capecitabine , until diseas progression, unacceptable toxicity, or voluntary withdrawal of informed consent
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 Objective Response Rate（ORR）
CR+PR
Overall Survival（OS）
Time from enrollment to death from any cause
DCR
CR+PR+SD
AEs
Safety analysis will be based on data from the safety population. It will primarily involve descriptive statistical analysis, with tables describing the adverse events that occurred in this study.
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