OncoMatch/Clinical Trials/NCT05771181
Vitamin E Combined With Fruquintinib and Tislelizumab in Microsatellite Stabilized Metastatic Colorectal Cancer Patients
Is NCT05771181 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Vitamin E and Fruquintinib for colorectal cancer.
Treatment: Vitamin E · Fruquintinib · Tislelizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS wild-type
Left-sided KRAS/NRAS/BRAF wild-type subjects received combined anti-EGFR mAb (cetuximab or panitumumab)
Required: NRAS wild-type
Left-sided KRAS/NRAS/BRAF wild-type subjects received combined anti-EGFR mAb (cetuximab or panitumumab)
Required: BRAF wild-type
Left-sided KRAS/NRAS/BRAF wild-type subjects received combined anti-EGFR mAb (cetuximab or panitumumab)
Required: MMR proficient
tumor tissue was pMMR by immunohistochemistry
Required: MSH2 microsatellite stable
MSS or MSI-L by PCR or NGS
Required: MSH2 microsatellite instability-low
MSS or MSI-L by PCR or NGS
Excluded: MMR deficient
Tumor tissues were dMMR detected by immunohistochemistry
Excluded: MSH2 microsatellite instability-high
MSI-H detected by PCR or NGS
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: fluorouracilines
Standard therapy was required to include all the following agents: fluorouracilines
Must have received: chemotherapy (irinotecan)
chemotherapy agents such as irinotecan
Must have received: chemotherapy (oxaliplatin)
oxaliplatin
Cannot have received: PD-1 antibody
Prior treatment with PD-1 antibody
Cannot have received: PD-L1 antibody
Prior treatment with PD-L1 antibody
Cannot have received: CTLA-4 antibody
Prior treatment with CTLA-4 antibody
Lab requirements
Blood counts
neutrophil ≥1.5*10^9/L; Platelet ≥100*10^9/L; Hemoglobin ≥9g/dl; Serum albumin ≥3g/dl
Kidney function
Serum creatinine ≤ 1.5 times the upper limit of normal, creatinine clearance ≥60ml/min
Liver function
bilirubin ≤ 1.5 times the upper limit of normal value; ALT and AST≤ 2 times the upper limit of normal
Good organ function: neutrophil ≥1.5*10^9/L; Platelet ≥100*10^9/L; Hemoglobin ≥9g/dl; Serum albumin ≥3g/dl; TSH ≤ 1x ULN, T3 and T4 in normal range; bilirubin ≤ 1.5x ULN; ALT and AST≤ 2x ULN; Serum creatinine ≤ 1.5x ULN, creatinine clearance ≥60ml/min; INR or PT ≤ 1.5x ULN unless on anticoagulant therapy and PT within intended range; aPTT ≤ 1.5x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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