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Brief Title: Vitamin E Combined With Fruquintinib and Tislelizumab in Microsatellite Stabilized Metastatic Colorectal Cancer Patients
Official Title: Phase II Clinical Study of Vitamin E Combined With Fruquintinib and Tislelizumab in Patients With Microsatellite Stabilized Metastatic Colorectal Cancer Who Failed Standard Therapy
Study ID: NCT05771181
Brief 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.
Detailed Description: Dietary supplements are commonly used during conventional cancer treatment. Vitamin E has a variety of functions, including enhancing immunity, anti-inflammation, and anti-oxidation. Tislelizumab is an anti-PD-1 monoclonal antibody, and furoquininib is a tyrosine kinase inhibitor that inhibits tumor angiogenesis. Studies have shown that immunotherapy combined with furoquininib has initial efficacy in the treatment of colorectal cancer. Whether vitamin E combined with immunotherapy and furoquininib can improve the prognosis of patients with colorectal cancer deserves to be studied. Therefore, the objective of this study is to evaluate the efficacy and safety of Vitamin E in combination with Fuquinitinib and Tirelizumab 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
270 Dongan Road, Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Name: Dawei Li, PhD
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR