RecruitingPhase 2

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

China48 participantsStarted 2025-12-01

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Written informed consent must be provided, and the patient must be able to comply with the visit schedule and procedures outlined in the protocol.
. Age ≥ 18 years and ≤ 75 years, regardless of gender.
. Histologically or cytologically confirmed, unresectable locally advanced or metastatic pMMR/MSS colorectal cancer.
. Patients must have progressed on standard therapy, be unsuitable for standard therapy due to intolerable toxicity, have no available standard therapy, or have refused standard therapy.
. Baseline\* hematology tests (within 7 days prior to the first dose of study drug) must meet the following criteria:Hemoglobin ≥ 90 g/L (without transfusion or erythropoietin support within 7 days prior to blood sampling).
.Throughout the protocol, "baseline" is defined as the last available observation prior to the first dose of the study drug. Patients must not have received any blood products or hematopoietic growth factor support within 7 days prior to the blood sample collection.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Progression Free Survival（PFS）

Timeframe: an expected average of 6 months

Trial details

NCT IDNCT07644286

SponsorTao Zhang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-25

Contact for this trial

Zhenyu Lin, MD

027-83262683 whxhlzy@hust.edu.cn

View on ClinicalTrials.gov More Colorectal Cancer (CRC) trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Written informed consent must be provided, and the patient must be able to comply with the visit schedule and procedures outlined in the protocol.
. Age ≥ 18 years and ≤ 75 years, regardless of gender.
. Histologically or cytologically confirmed, unresectable locally advanced or metastatic pMMR/MSS colorectal cancer.
. Patients must have progressed on standard therapy, be unsuitable for standard therapy due to intolerable toxicity, have no available standard therapy, or have refused standard therapy.
. Baseline\* hematology tests (within 7 days prior to the first dose of study drug) must meet the following criteria:Hemoglobin ≥ 90 g/L (without transfusion or erythropoietin support within 7 days prior to blood sampling).
.Throughout the protocol, "baseline" is defined as the last available observation prior to the first dose of the study drug. Patients must not have received any blood products or hematopoietic growth factor support within 7 days prior to the blood sample collection.

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria