drugset / Trial / NCT05771181

Vitamin E Combined With Fruquintinib and Tislelizumab in Microsatellite Stabilized Metastatic Colorectal Cancer Patients

NCT05771181

Phase 2 Recruiting 25 enrolled Fudan University
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to learn about efficacy of Vitamin E in combination with Fuquinitinib and Tirelizumab in patients with microsatellite stabilized mCRC who have failed standard therapy. The main question is to explore the survival time, safety and tolerability of the treatment. At the same time, the correlation between biomarkers (including PD-L1 expression, tumor mutation load, lymphocyte subpopulation, cytokines, TCR, intestinal microbes, and others) and the efficacy and drug resistance mechanism will be analyzed, so as to provide reference for the subsequent guidance of the screening of benefit groups.

Timeline

Start
2023-03-01
Primary completion
2025-12
Completion
2027-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Fruquintinib Small molecule 5 mg Oral
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous
Subject Vitamin E Other / unclassified 400 mg Oral

Indications