Irinotecan Liposome (II) or Etoposide Combined With Adebrelimab and Carboplatin in the Treatment of ES-SCLC
Trial Parameters
Brief Summary
This study is a prospective, randomized, parallel, multicenter phase II study aimed at evaluating the efficacy and safety of irinotecan liposome (II) or etoposide combined with adebrelimab and carboplatin as first-line treatment for extensive stage small cell lung cancer. The primary endpoint of the study was the 1-year overall survival rate.
Eligibility Criteria
Inclusion Criteria: * Pathologically confirmed small cell lung cancer (SCLC), staged as extensive-stage SCLC (ES-SCLC) according to the VALG staging system; * No prior systemic treatment received; * At least a 6-month interval between the last treatment (radiation therapy and chemotherapy) and diagnosis of extensive-stage SCLC; * Showing at least one target lesion (RECIST 1.1) that has not been previously irradiated; * Male or female patients aged ≥18 and ≤70 years; * ECOG performance status (PS) score of 0 or 1; * Life expectancy of ≥12 weeks; * Adequate organ function: (1) Hematologic: WBC ≥ 3.0 × 10⁹/L, ANC ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L, HGB ≥ 9.0 g/dL.(2) Hepatic function: AST ≤ 2.5 × ULN, ALT ≤ 2.5 × ULN, liver metastases allowed if ALT and AST ≤ 5 × ULN, TBIL ≤ 1.5 × ULN (except for Gilbert's syndrome, where total bilirubin ≤ 3.0 mg/dL),(3) Renal function: Cr ≤ 1.5 × ULN or CrCl ≥ 50 mL/min, (4) Coagulation: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN; * Agreement to use an appropriate