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RECRUITING
NCT06484153
PHASE2

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

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized Phase 2 Clinical Trial Evaluating Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Patients With Standard Treatment Failure of Advanced or Metastatic pMMR/MSS Colorectal Carcinoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2024-07-22

Completion Date

2026-12-30

Last Updated

2026-08-18

Healthy Volunteers

No

Interventions

DRUG

Pirfenidone

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.

DRUG

Fruquintinib

3mg, orally, qd

DRUG

Pembrolizumab

200mg iv every 3 weeks

Locations (1)

Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China