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Brief Title: A Study to Explore the Third-line Treatment of Fruquintinib Combined With Serplulimab in Advanced Non-isolated Hepatic Metastatic Colorectal Cancer: a Single-center, Phase 2 Study
Official Title: A Study to Explore the Third-line Treatment of Fruquintinib Combined With Serplulimab in Advanced Non-isolated Hepatic Metastatic Colorectal Cancer: a Single-center, Phase 2 Study
Study ID: NCT05954429
Brief Summary: The aim of this clinical trial is to learn about efficacy of fruquintinib combined with serplulimab in patients with microsatellite stabilized mCRC who have failed standard therapy. The main purpose is to explore efficacy, safety and tolerability of the treatment. At the same time, the correlation between biomarkers (including ctDNA, TPS, CPS, tumor mutation burden, lymphocyte subpopulation, cytokines, TCR, intestinal microbes, etc.) and the efficacy and drug resistance mechanism will be analyzed, which could provide reference for determining the advantaged group.
Detailed Description: Serplulimab is an anti-PD-1 monoclonal antibody, and fruquintinib is a tyrosine kinase inhibitor that inhibits tumor angiogenesis. Studies have shown that immunotherapy combined with fruquintinib has preliminary efficacy in the treatment of colorectal cancer. Whether serplulimab combined with fruquintinib can improve the prognosis of patients with colorectal cancer remains to be determined. Therefore, the study is to evaluate the efficacy and safety of serplulimab combination with fruquintinib in patients with microsatellite stabilized mCRC who have failed standard therapy.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China