Phase II Randomized Study of Serplulimab Added to Second-Line Chemotherapy and Targeted Therapy for Early Relapse Colorectal Cancer After Adjuvant Chemotherapy

What this Trial Is About

Researchers are evaluating treatments for patients with colorectal cancer who experience early relapse within one year after completing adjuvant chemotherapy with XELOX or FOLFOX. These patients have a poor prognosis, limited treatment options, and most have tumors resistant to immune checkpoint inhibitor monotherapy. This phase II randomized trial aims to assess the safety and effectiveness of adding serplulimab, a PD-1 inhibitor, to second-line chemotherapy plus targeted therapy in this high-risk group. Participants will be randomly assigned to one of two groups the experimental arm receiving serplulimab combined with FOLFIRI chemotherapy and targeted therapy, or the control arm receiving FOLFIRI plus targeted therapy alone. Treatment regimens vary based on tumor location and RAS mutation status, with cetuximab used for left-sided, RAS wild-type tumors and bevacizumab for right-sided, RAS mutant tumors. Serplulimab is administered intravenously every two weeks at 3 mgkg. The study uses a Pick-the-Winner design to enroll 40 patients total. During the study, researchers will monitor progression-free survival over 12 months as the primary outcome. Secondary outcomes include objective response rate, disease control rate, overall survival over 36 months, and safety assessments using standard criteria. Exploratory analyses will examine tumor and blood biomarkers to identify predictors of response and resistance. Participants will undergo scheduled visits, treatments, laboratory tests, and assessments throughout the study period to evaluate these outcomes.

A Phase II Randomized Trial of Serplulimab With Second-Line Chemo/Targeted Therapy for Early Relapse Colorectal Cancer After Adjuvant Chemotherapy