The Efficiency of Surgery and Radiotherapy After SHR-1316 (Adebrelimab) and Platinum-containing Doublet Induction Therapy for Limited-stage Small Cell Lung Cancer

Korábbi kezelés

• 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;
• Patients who have undergone other major surgery or severe trauma within 2 months before the start of the trial;

Más betegség

• 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;
• Those who suffer from neurological diseases or mental illnesses who cannot cooperate;

Egyéb

• Pregnant or breastfeeding women;
• Other reasons that investigators deem inappropriate for enrollment.

• 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.