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 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.
All colorectal cancer patients must have confirmed MSS/pMMR status; patients with MSI-H/dMMR are excluded.
History of hypersensitivity to any study drug components, including PD-1 inhibitors and pirfenidone.
Female patients who are pregnant, lactating, or planning to become pregnant within 6 months after the last dose of the study drug.
Known history or presence of active seizure disorder, active central nervous system metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease. Patients with newly identified brain or leptomeningeal metastases are excluded.
Parallel
Pirfenidone in combination with a PD-1 inhibitor
DrugThe 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.
hypofractionated radiotherapy
Radiationhypofractionated radiotherapy
Progression Free Survival（PFS）
Progression-free survival (PFS) is defined as the time from the initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever comes first.
Overall Survival
The time from the date of randomization to the death caused by any cause
Objective Response Rate
The proportion of patients in a study cohort whose best overall response achieves either a complete response (CR) or a partial response (PR), as defined by standardized oncologic criteria (such as RECIST 1.1), during the course of the treatment period.
dverse events (AEs) were graded according to the NCI CTCAE version 5·0
Adverse events and surgical safety
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Tao Zhang
Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Sponsor institution
