Recruiting nowPhase 2Randomised
What this trial is trying to do
The researchers are testing whether pirfenidone, an anti-fibrotic drug, combined with a PD-1 inhibitor, which helps immune cells recognise cancer, can control advanced colorectal cancer that has resisted previous treatment. They are also testing whether adding short-course, higher-dose radiotherapy to this combination improves cancer control.
The comparison is the same drug combination with or without hypofractionated radiotherapy, and the main question is whether radiotherapy helps patients go longer before the cancer grows, measured as progression-free survival. The trial will also assess safety and tolerability, rather than measuring survival directly.
Worth knowing: This is a small phase II trial in people with advanced, treatment-resistant pMMR/MSS colorectal cancer, so progression-free survival may not translate into longer overall survival.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07644286 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | randomised, open label |
| Taking part | 48 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Tao Zhang |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Pirfenidone in combination with a PD-1 inhibitor
- Radiotherapy hypofractionated radiotherapy
What it is measuring
Progression Free Survival（PFS）
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Locally advanced
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
1. Written informed consent must be provided, and the patient must be able to comply with the visit schedule and procedures outlined in the protocol.
2. Age ≥ 18 years and ≤ 75 years, regardless of gender.
3. Histologically or cytologically confirmed, unresectable locally advanced or metastatic pMMR/MSS colorectal cancer.
4. 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.
5. 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).
Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L (without granulocyte colony-stimulating factor support within 7 days prior to blood sampling).Platelet count ≥ 100 × 10⁹/L (without transfusion support within 7 days prior to blood sampling).Eosinophil count ≤ 1.5 × ULN.
9.Throughout the protocol, "baseline" is defined as the last available observation prior to the first dose of the study drug.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: China.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07644286, registered by Tao Zhang on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.