OncoMatch/Clinical Trials/NCT07644286
A Phase II Study of Pirfenidone Plus PD-1 Inhibitor With or Without Hypofractionated Radiotherapy for Refractory pMMR/MSS Colorectal Cancer
Is NCT07644286 recruiting? Yes, currently enrolling (Jul 2026). This Phase 2 trial studies Pirfenidone in combination with a PD-1 inhibitor for colorectal cancer (crc).
Treatment: Pirfenidone in combination with a PD-1 inhibitor — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Required: Mismatch-repair proficient (pMMR / MSS)
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: standard therapy
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.
Lab requirements
Blood counts
Hemoglobin ≥ 90 g/L (no transfusion/erythropoietin support within 7 days prior to sampling). ANC ≥ 1.5 × 10⁹/L (no G-CSF support within 7 days prior to sampling). Platelet count ≥ 100 × 10⁹/L (no transfusion support within 7 days prior to sampling). Eosinophil count ≤ 1.5 × ULN.
Kidney function
Serum creatinine ≤ 1.5 × ULN or Calculated Creatinine Clearance (CrCl) ≥ 45 mL/min (Cockcroft-Gault formula, actual body weight).
Liver function
Total bilirubin ≤ 1.5 × ULN (if total bilirubin is >1.5 × ULN, direct bilirubin must be ≤ ULN for inclusion). AST and ALT ≤ 3 × ULN. Albumin ≥ 30 g/L.
Baseline hematology, biochemistry, and urinalysis criteria as specified.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07644286 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received standard therapy.
Does this trial require MLH1?
Yes, MLH1 wild-type is a required biomarker for enrollment.
Does this trial require MSH2?
Yes, MSH2 wild-type is a required biomarker for enrollment.
Does this trial require MSH6?
Yes, MSH6 wild-type is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages