Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Advanced or Metastatic pMMR/MSS Colorectal Carcinoma

Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study ID
NCT06484153
Phase
PHASE2
Status
Recruiting
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Conditions

  • Combination of Fruquintinib and Anti-PD-1 Antibody Was Reported to Improve Patient Prognosis in Colorectal Cancer
  • To Evaluate Whether Pirfenidone Can Reshape the Tumor Microenvironment in Colorectal Cancer
  • To Evaluate the Efficacy of Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Colorectal Carcinoma

Eligibility Criteria

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

Interventions

  • Pirfenidone — DRUG
    Pirfenidone: Day 1 to Day 14: 200 mg, oral administration (po), three times daily (tid); Day 15 to Day 29: 400 mg, po, tid; Day 30 until progressive disease: 600 mg, po, tid.
  • Fruquintinib — DRUG
    3mg, orally, qd
  • Pembrolizumab — DRUG
    200mg iv every 3 weeks

Study Details

The purpose of this study is to evaluate the efficacy and safety of fruquintinib and pirfenidone in combination with anti-PD-1 antibody in patients with standard treatment failure of advanced or metastatic pMMR/MSS colorectal adenocarcinoma.

Key Dates

First listed
Jul 3, 2024
Start date
Jul 22, 2024
Status verified
Dec 2025
Primary completion
Jul 22, 2026
Completion
Dec 30, 2026

Study Design

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

Arms

  • Experimental: Treatment
    Pembrolizumab intravenous (IV) 200mg flat dose day 1 then every 3 weeks. Fruquintinib orally (PO) 3mg po qd. Pirfenidone (Esbriet) orally (PO) with food according to this schedule: d1-d14: 200mg po tid; d15-d29: 400mg po tid; d30-PD: 600mg po tid.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: 2 year ]

Central Contacts