A Prospective，Single Center, Randomized Control，Phase III Clinical Study for Evaluating the Safety and Efficacy of Pembrolizumab Combined With MWA for Patients With Stage ⅢB-Ⅳ NSCLC Who Failed With First-line Therapy
This is a prospective, randomized, single clinical study designed to evaluate its safety and efficacy by using Microwave Ablation combine with Pembrolizumab in patients with Stage ⅢB-Ⅳ Non-small Cell Lung.Cancer (NSCLC) who failed with first-line therapy.
• Pathologically diagnosed IIIB or IV non-small cell lung cancer.
• Previously accepted first-line standard treatment failure or recurrence
• At least one measurable lesion.
• The patient has not received any other anti-cancer treatment within four weeks.
• Any gender, age ≥18 years
• ECOG PS : 0-2 points
• Expected survival ≥ 6 months
• The level of organ function meets the following criteria.
⁃ (1) subject to the standard blood test: ANC ≥ 1.5×109 / L, PLT ≥ 50×109 / L, Hb ≥ 90g/L.
⁃ (2) biochemical tests must meet the following criteria: TBIL\<1.5×ULN, ALT, AST \<2.5×ULN ( if liver metastasis ALT, AST can be \<5×ULN), BUN, and Cr ≤ 1×ULN).
⁃ 9\. Female patients in child bearing period must have evidence of negative pregnancy test, and agree to take effective contraceptive measures until 6months after therapy.
⁃ 10\. Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.