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

Sponsor
The First Hospital of Jilin University
Study ID
NCT06979908
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Fruquintinib+Sintilimab+Chidamide — DRUG
    Fruquintinib: 5 mg orally once daily on days 1-14 of each 21-day cycle (Q3W). Sintilimab (anti-PD-1): 200 mg intravenously on day 1 of each cycle (first infusion over 60 minutes, subsequent infusions over 30-60 minutes, Q3W). Chidamide: 30 mg orally twice weekly (BIW; e.g., Monday \& Thursday or Tuesday \& Friday, with ≥3 days between doses), taken 30 minutes after meals.

Study Details

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.

Key Dates

First listed
May 20, 2025
Start date
Jan 22, 2025
Status verified
May 2025
Primary completion
Jul 22, 2026
Completion
Jan 22, 2027

Study Design

Enrollment
46 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Arm
    Fruquintinib: 5 mg, once daily, orally, on days 1-14, every 3 weeks (Q3W); Sintilimab (PD-1 inhibitor): 200 mg, once per cycle, intravenous infusion (first infusion over 60 minutes, subsequent infusions over 30-60 minutes), on day 1, Q3W; Chidamide: 30 mg, twice weekly (BIW), orally (with at least 3 days between doses, taken 30 minutes after meals).

Primary Outcome Measure

PFS [ Time Frame: 24 months ]

Central Contacts

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