Surgery or Radiotherapy After PD-L1 Inhibitor (TQB-2450) and Chemotherapy Induction Therapy in Patients With Limited-stage Small-cell Lung Cancer
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.
• The patient shall sign the Informed Consent Form.
• Aged 18 ≥ years.
• Histological or cytological diagnosis of SCLC by needle biopsy, and extensive stage or limited stage (local advanced) confirmed by imageological examinations.
• Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
• Life expectancy is at least 12 weeks.
• At least 1 measurable lesion according to RECIST 1.1.
• 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.
• Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of TQB2450 (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
• Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of TQB2450 (whichever is later).