Actively Recruiting
Vitamin E Combined With Fruquintinib and Tislelizumab in Microsatellite Stabilized Metastatic Colorectal Cancer Patients
Led by Fudan University · Updated on 2025-06-12
25
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Vitamin E Combined With Fruquintinib and Tislelizumab in Microsatellite Stabilized Metastatic Colorectal Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Histologically or cytologically confirmed unresectable and metastatic colorectal cancer
- Disease progression or intolerance to prior standard therapy including fluorouracil, irinotecan, oxaliplatin, and with or without anti-VEGF or anti-EGFR antibodies
- Tumor tissue confirmed microsatellite stable or pMMR by immunohistochemistry, PCR, or NGS
- ECOG performance status 0-1 and expected survival of at least 3 months
- At least one measurable tumor lesion by RECIST 1.1 criteria
- Adequate organ function including specified blood counts, liver and kidney function, thyroid hormones, coagulation parameters
- No serious concomitant diseases reducing expected survival to less than 5 years
- Negative pregnancy test for females of childbearing potential; infertile females
- Agreement to use adequate contraception during treatment and for 12 months after
- Signed informed consent
- Willingness and ability to follow the visit schedule, treatment plan, and study procedures
- No participation in other drug or medical device clinical research during the study period
You will not qualify if you...
- Diagnosis of other intestinal tumors such as gastrointestinal stromal tumor
- Tumor tissue showing dMMR or MSI-High by immunohistochemistry or molecular testing
- Prior treatment with PD-1, PD-L1, or CTLA-4 antibodies
- History of other malignancies except certain treated skin, cervical, or thyroid cancers
- Active or history of autoimmune diseases requiring immunosuppression, except specified stable conditions
- Immunodeficiency conditions including HIV infection or history of organ/bone marrow transplant
- Contraindications to antiangiogenic drugs such as active bleeding
- History of interstitial lung disease or non-infectious pneumonia
- Active or recent pulmonary tuberculosis infection
- Active hepatitis B or C infection as defined by viral load criteria
- Severe heart, lung, or kidney dysfunction
- Poorly controlled hypertension despite medication
- History of substance abuse including alcohol and drugs
- Other medical or social conditions that may affect safety or compliance as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
270 Dongan Road, Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
D
Dawei Li, PhD
CONTACT
Z
Zhiyu Chen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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