Efficacy and Safety of Postoperative Adjuvant Chemotherapy Combined With Camrelizumab for Patients With ⅡA -ⅢA Non-small Cell Lung Cancer：a Phase II , Single-arm Clinical Study
Postoperative adjuvant chemotherapy followed by immunotherapy for non-small cell lung cancer has become a new treatment recommendation, but there are still many clinical problems to be solved in postoperative adjuvant immunotherapy. This study aims to explore the efficacy and safety of adjuvant chemotherapy combined with immunotherapy in patients with stage IIA-IIIA non-small cell lung cancer after surgery. Patients who meet the protocol and sign the informed consent form received 4 cycles of chemotherapy combined with camrelizumab, followed by maintenance with camrelizumab until one year or the disease progressed or unacceptable toxicity.
• Sign the informed consent form before starting the study;
• For patients with non-small cell lung cancer who have undergone surgical resection, the TNM stage after surgery is IIA-IIIA;
• Patients cannot receive targeted adjuvant therapy;
• 18-80 years old;
• The patient can recover within 3-8 weeks after the operation, and receive postoperative adjuvant treatment;
• The ECOG PS score is 0 or 1;
• Have not received any chemotherapy for non-small cell lung cancer before enrollment;
• Within 7 days before enrollment, the laboratory inspection must meet all the following requirements:
‣ Absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, hemoglobin ≥ 9g/dL;
⁃ Total bilirubin ≤ 1.5 ULN; AST and ALT ≤ 2.5 ULN;
⁃ Serum creatinine ≤ 1.25 ULN, or serum creatinine clearance ≥ 60ml/min;
• Female patients must meet: menopause or have undergone surgical sterilization. Women with fertility must take effective contraceptive measures. Do not breastfeed.
⁃ Male patients must agree to use appropriate contraceptive measures.