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A Phase II Study of Pirfenidone Plus PD-1 Inhibitor With or Without Hypofractionated Radiotherapy for Refractory pMMR/MSS Colorectal Cancer

NCT07644286 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-06-12

No results posted yet for this study

Summary

This study aims to evaluate the safety, tolerability, and efficacy of pirfenidone and PD-1 monoclonal antibody combined with or without hypofractionated radiotherapy in the treatment of advanced refractory pMMR/MSS colorectal cancer patients.

Conditions

  • Colorectal Cancer (CRC)

Interventions

DRUG

Pirfenidone in combination with a PD-1 inhibitor

The PD-1 inhibitor will be administered intravenously at 200 mg every 3 weeks. Pirfenidone dosing will follow an escalating regimen: 200 mg orally three times daily, 400 mg orally three times daily, and 600 mg orally three times daily.

RADIATION

hypofractionated radiotherapy

hypofractionated radiotherapy

Sponsors & Collaborators

  • Tao Zhang

    lead OTHER

Principal Investigators

  • Tao Zhang, MD · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2027-01-25
Completion
2027-12-25

Countries

  • China

Study Locations

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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 NCT07644286 on ClinicalTrials.gov