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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

NCT06979908 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-05-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Fruquintinib+Sintilimab+Chidamide

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.

Sponsors & Collaborators

  • The First Hospital of Jilin University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-22
Primary Completion
2026-07-22
Completion
2027-01-22

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06979908 on ClinicalTrials.gov