Build a multimodal big data platform and a multi-omics high-throughput detection system to screen and validate the efficacy and toxicity biomarkers of radioimmunotherapy combined with other treatments

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: Trial group:Trial group: Pirfenidone capsules + basic treatment; Pirfenidone capsules 100mg per capsule. Week 1: oral 2 capsules per dose, 3 times daily, starting from day 2 after enrollment; Week 2: oral 3 capsules per dose, 3 times daily; Weeks 3‐8: oral 4 capsules per dose, 3 times daily; all doses taken with meals or after meals. After 8 weeks of treatment, if the investigator judges the subject to benefit, it is recommended to continue taking the medication up to 24 weeks.;Control group:Control group: Placebo + basic treatment. The placebo used in the placebo group is made to be identical to pirfenidone capsules in appearance, packaging, and odor.; CONDITION: Non small cell lung cancer, radiation or immune pneumonia PRIMARY OUTCOME: The percentage of patients hospitalized or who died for any reason related to acute lung exacerbation at 24 weeks; SECONDARY OUTCOME: The changes in DLCO%, FVC and FEV1 at week 24 compared with the baseline;The changes in CT scores at week 24 compared with the baseline;The changes in the classification of cough, dyspnea and fever symptoms at week 24 compared with the baseline;Progression‐free survival (PFS) of patients with different cancer types;The overall survival period of patients classified by cancer type; INCLUSION CRITERIA: 1. Age range: 18‐75 years old (including 18 and 75 years old); 2. Pathologically diagnosed non‐small cell lung cancer, small cell lung cancer, or esophageal cancer patients; 3. Whole body condition assessment, ECOG 0‐2; 4. Those with an expected survival period of more than 6 months; 5. Clinically diagnosed grade 2‐3 radiation‐induced or immune induced lung injury; 6. The duration of radiation‐induced or immune induced lung injury is less than 2 months; 7. The functional level of major organs meets the following standards; 8. The blood routine examination standards must meet the following criteria: ANC >= 3.0 X10^9/L, PLT >= 100 X10^9/L, Hb >= 90 g/L; 9. Biochemical tests must meet the following standards: TBIL, BUN, and Cr <= 1.5 XULN, ALT and AST <= 2.0 XULN; 10. The subjects voluntarily joined this study and signed an informed consent form.
Epistemonikos ID: 4bbf90caa8fe402a5283d9c8d4ab0768caca6670
First added on: Oct 08, 2026