About this trial

By establishing a prospective clinical cohort for small cell lung cancer (SCLC) and systematically collecting high-quality real-world data integrating clinical, imaging, pathological, and molecular dimensions, this study aims to enable personalized treatment for distinct SCLC subtypes. Furthermore, by evaluating the influence of radiotherapy timing, dose and fractionation, and target selection on efficacy and toxicity, we aim to identify the optimal radio-immunotherapy combination regimen that maximizes the synergistic effect in SCLC patients.

Eligibility criteria

Qualifiers

Hematology: Hemoglobin (Hb) ≥ 90 g/L, absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, platelet count (PLT) ≥ 90 × 10⁹/L.

Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); serum total bilirubin (TBIL) ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN in patients without liver metastases, or ≤ 5.0 × ULN in patients with liver metastases; serum albumin (ALB) ≥ 25 g/L.

Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN; prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for patients receiving prophylactic anticoagulation, the INR and APTT values should be judged by the treating physician or investigator to be within a safe and effective therapeutic range).

Hematology: Hemoglobin (Hb) ≥ 90 g/L, absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, platelet count (PLT) ≥ 90 × 10⁹/L.

Disqualifiers

Histologically confirmed non-small cell lung cancer (NSCLC).

No efficacy assessment record, or missing efficacy assessment data.

Presence of other primary malignancies; history of allogeneic organ transplantation.

Major surgery (excluding diagnostic biopsy) within 4 weeks prior to the first dose.

Trial design

Treatments tested in this trial

  • radiatherapy, and chemotherapy with or without immunotherapy as clinical practice

Treatment groups

500 Participants
are divided into 1 treatment group

Locations

1
Shanghai Chest Hospital200030, ShanghaiShanghai Municipality, China

Sponsors and collaborators

Shanghai Chest Hospital

Lead sponsor