RecruitingPhase 2NCT05771181

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

Sponsor

Fudan University

Enrollment

25 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer Microsatellite Stable Colorectal Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a combination of three treatments — Vitamin E, a targeted cancer drug called fruquintinib, and an immunotherapy drug called tislelizumab — for people with colorectal cancer that has spread (metastatic) and has a specific molecular feature called microsatellite stability (MSS). MSS colorectal cancers are typically harder to treat with immunotherapy alone, so researchers are testing this new combination. **You may be eligible if...** - You are 18 or older with colorectal cancer that has spread and cannot be removed by surgery - Your cancer has been confirmed by a lab test (biopsy) - You have already tried and progressed on standard chemotherapy treatments (including fluorouracil, irinotecan, and oxaliplatin) - Your cancer is confirmed to be microsatellite stable (MSS) **You may NOT be eligible if...** - You have not yet tried standard chemotherapy - Your cancer has a different molecular profile (e.g., MSI-high) - You have serious heart, liver, or organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVitamin E

Vitamin E: 400mg (QD), oral, once daily, continued until disease progression or intolerable toxicity.

DRUGFruquintinib

Fuquinitinib: 5mg (QD) orally for 2 weeks, 1 week off, repeated every 3 weeks until disease progression or intolerable toxicity.

DRUGTislelizumab

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.