NCT05771181

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

Phase II Clinical Study of Vitamin E Combined With Fruquintinib and Tislelizumab in Patients With Microsatellite Stabilized Metastatic Colorectal Cancer Who Failed Standard Therapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer
• Microsatellite Stable Colorectal Carcinoma

Interventions

Type	Name	Description
DRUG	Vitamin E	Vitamin E: 400mg (QD), oral, once daily, continued until disease progression or intolerable toxicity.
DRUG	Fruquintinib	Fuquinitinib: 5mg (QD) orally for 2 weeks, 1 week off, repeated every 3 weeks until disease progression or intolerable toxicity.
DRUG	Tislelizumab	Tislelizumab: 200mg intravenously every 3 weeks (Q3W), was administered until the occurrence of unacceptable toxic effects, or disease progression, withdrawal of consent, or withdrawal as judged by the investigator.

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-12-01
• Completion: 2027-02-01
• First posted: 2023-03-16
• Last updated: 2025-06-12

Locations

1 site across 1 country: China