the efficiency of surgery and radiotherapy after shr-1316 (adebrelimab) and platinum-containing doublet induction therapy for limited-stage small cell lung cancer

Conditions: Limited Stage Small Cell Lung Cancer

Summary: to compare the efficiency between surgery and radiotherapy after shr-1316 (adebrelimab)and platinum-containing doublet induction therapy for limited-stage small cell lung cancer

1.1 main purpose to compare the efficiency between surgery and radiotherapy after therapy with shr-1316 and chemotherapy for limited-stage small cell lung cancer according to progression-free survival (pfs) 1.2 secondary purpose the incidence of adverse events (aes) during treatment was assessed to identify the safety of shr-1316 and chemotherapy combined with surgery or radiotherapy according to the national cancer institute common terminology criteria for adverse events (nci-ctcae) v5.0. to evaluate the pathological response rate (mpr and pcr) of the surgical population after neoadjuvant therapy with shr-1316 and chemotherapy for operable ld-sclc according to the evaluation criteria of pathological response after neoadjuvant therapy recommended by the international association for the study of lung cancer (iaslc); to evaluate the overall survival (os) of patients with limited-stage small cell lung cancer after therapy with shr-1316 and chemotherapy combined with surgery or radiotherapy to evaluate the recurrence-free survival (rfs) in patients with limited-stage small cell lung cancer who received neoadjuvant shr-1316 and chemotherapy combined with surgery; to evaluate the duration of response (dor) in patients with limited-stage small cell lung cancer after shr-1316 and chemotherapy combined with surgery or radiotherapy according to recist v1.1 to identify the impact on the health-related quality of life (hrqol), mood, symptoms, sleep, etc. of patients undergoing surgery and radiotherapy after therapy with shr-1316 and chemotherapy according to the pulmonary hospital psychological assessment scale; 1.3 exploratory purpose to explore potential predictive biomarkers in archived and/or fresh tumor tissue and/or blood (or blood derivatives), including but not limited to programmed cell death protein ligand 1 (pd-l1) expression as determined by immunohistochemistry (ihc), gene expression profile (gep), tumor mutational burden (tmb), tumor-infiltrating immune cell changes, etc., to evaluate the association of these markers with the study of treatment response or resistance mechanisms.

Eligibility criteria:
inclusion criteria: * after signing informed consent; * aged 18-70; * histologically or cytologically confirmed sclc, imaging examination and other confirmed limited-stage small cell lung cancer, and without previous treatment; * for clinical stage iib-iii, all patients should have clear lymph node pathology by ebus to exclud occult lymph node metastasis. * two thoracic surgeons assessed thar it would be able to achieve radical surgery or r0 resection after 4 cycles of treatment. surgical approaches include lobectomy, sleeve resection and pneumonectomy * ecog performance status score 0-1 points; * with a life expectancy of at least 12 weeks; * at least one measurable tumor * with normal other major organs (liver, kidney, blood system, etc.) function: absolute neutrophil count (anc) ≥1.5×109/l, platelets ≥100×109/l, hemoglobin ≥90 g/l. note: patients should not receive blood transfusion or growth factor support within ≤ 14 days before blood collection during the screening period; - international normalized ratio (inr) or prothrombin time (pt) ≤ 1.5 × upper limit of normal (uln); activated partial thromboplastin time (aptt) ≤ 1.5×uln; serum total bilirubin ≤ 1.5×uln (total bilirubin in patients with gilbert syndrome must be \<3×uln); aspartate and alanine aminotransferase (ast and alt) ≤2.5×uln, or ast and alt ≤5×uln in patients with liver metastases * female patients of childbearing potential must voluntarily use highly effective contraception during the study period until ≥ 120 days after the last dose of chemotherapy or shr-1316, whichever is later, and have ≤ 7 days of urine or serum pregnancy test results are negative; * unsterilized male patients must voluntarily use highly effective contraception during the study period until ≥120 days after the last dose of chemotherapy or shr-1316, whichever is later. exclusion criteria: * received any systemic anticancer therapy, including surgery, local radiotherapy, cytotoxic drug therapy, targeted drug therapy, and experimental therapy; * patients with other malignancies within five years prior to the start of the trial; * combined with unstable systemic diseases, such as uncontrolled hypertension, severe arrhythmia, etc; * with active, known or suspected autoimmune disease, or autoimmune paraneoplastic syndrome requiring systemic therapy; * allergy to the test drug; * have or currently have interstitial lung disease; * coexisting with hiv infection or active hepatitis; * patients who have undergone other major surgery or severe trauma within 2 months before the start of the trial; * pregnant or breastfeeding women; * those who suffer from neurological diseases or mental illnesses who cannot cooperate; * other reasons that investigators deem inappropriate for enrollment.

Keywords: ld-sclc surgery radiotherapy neoadjuvant chemoimmunotherapy