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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

Colorectal Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05954429
Study type Interventional
Source Fudan University
Contact
Status Not yet recruiting
Phase Phase 2
Start date July 20, 2023
Completion date August 31, 2026
View Details
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