PD-L1 Antibody (TQB2450) Plus Chemotherapy for Previously Untreated Limited- Stage Small-cell Lung Cancer
Trial Parameters
Brief Summary
This is a non-randomized, open-label, single-center, phase II trial to evaluate the safety and effectiveness of surgery or radiotherapy after PD-L1 inhibitor (TQB2450) and chemotherapy induction therapy followed by maintenance therapy as first-line treatment in patients limited-stage SCLC.
Eligibility Criteria
Inclusion Criteria: 1. The patient shall sign the Informed Consent Form. 2. Aged 18 ≥ years. 3. Histological or cytological diagnosis of SCLC by needle biopsy, and extensive stage or limited stage (local advanced) confirmed by imageological examinations. 4. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1. 5. Life expectancy is at least 12 weeks. 6. At least 1 measurable lesion according to RECIST 1.1. 7. Patients with good function of other main organs (liver, kidney, blood system, etc.): * ANC count ≥1.5×10\^9/L, platelet count ≥100×10\^9/L，hemoglobin ≥90 g/L; * the international standard ratio of prothrombin time (INR) and prothrombin time (PT) \< 1.5 times of upper limit of normal (ULN); * partial thromboplastin time (APTT) ≤1.5×ULN; * total bilirubin ≤1.5×ULN; * alanine aminotransferase (ALT) aspartate aminotransferase (AST) ≤2.5×ULN, or ALT and AST ≤5×ULN in the patients with liver metastatic tumor. 8. Fertile female patients must voluntarily use effec