OncoMatch/Clinical Trials/NCT06979908
A Clinical Study on the Efficacy and Safety of Fruquintinib in Combination With PD-1 Monoclonal Antibody and Chidamide in Refractory MSS Metastatic Colorectal Cancer
Is NCT06979908 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Fruquintinib+Sintilimab+Chidamide for metastatic colorectal cancer.
Treatment: Fruquintinib+Sintilimab+Chidamide — This study is a single-arm, open-label, single-center clinical trial designed to evaluate the efficacy and safety of fruquintinib in combination with a PD-1 inhibitor and chidamide in patients with refractory MSS-type metastatic colorectal cancer (mCRC). A total of 46 patients are planned to be enrolled, with the primary endpoint being median progression-free survival (mPFS). Secondary endpoints include median overall survival (mOS), objective response rate (ORR), and safety.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: immune checkpoint inhibitor
Prior immune checkpoint inhibitor therapy (e.g., anti-CTLA-4, anti-PD-1, anti-PD-L1)
Cannot have received: immunostimulatory agent (IFN, IL-2)
Immunostimulatory agents (e.g., IFN, IL-2) within 4 weeks before study treatment, or 5 drug elimination half-lives (whichever is longer)
Cannot have received: chemotherapy
Chemotherapy, immunotherapy (e.g., IL, IFN, thymosin), or any investigational therapy within 14 days before study treatment, or 5 drug elimination half-lives (whichever is longer)
Lab requirements
Blood counts
ANC ≥1.5 × 10⁹/L (1500/µL); Platelet count ≥100 × 10⁹/L (100,000/μL); Hemoglobin ≥90 g/L (9 g/dL)
Kidney function
Serum creatinine ≤1.5 × ULN and creatinine clearance ≥60 mL/min
Liver function
For patients without liver metastases: AST/ALT ≤2.5 × ULN; For patients with liver metastases: AST/ALT ≤5 × ULN; Total bilirubin ≤1.5 × ULN
Adequate bone marrow, liver, and renal function: ANC ≥1.5 × 10⁹/L (1500/µL) Platelet count ≥100 × 10⁹/L (100,000/μL) Hemoglobin ≥90 g/L (9 g/dL) For patients without liver metastases: AST/ALT ≤2.5 × ULN For patients with liver metastases: AST/ALT ≤5 × ULN Total bilirubin ≤1.5 × ULN Serum creatinine ≤1.5 × ULN and creatinine clearance ≥60 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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