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 (Jun 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
Treatments studied
Other
Cancer type
Colorectal Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT06979908 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior immune checkpoint inhibitor, immunostimulatory agent, chemotherapy disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages