Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure

Exclusion Criteria

• •Male or female patients aged ≥18 years who have provided written informed consent.
• •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, with an expected survival of more than 6 months, and deemed suitable for microwave ablation by the investigator.
• •Patients must have previously received first-line treatment with tislelizumab in combination with chemotherapy and have documented disease progression based on imaging assessments prior to enrollment. Disease progression must occur ≥6 months after initiation of first-line tislelizumab plus chemotherapy, with or without concomitant anti-angiogenic therapy.
• •Adequate organ and bone marrow function, defined as follows:
• •Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L Platelet count ≥100 × 10⁹/L Hemoglobin ≥90 g/L White blood cell count ≥3.0 × 10⁹/L
• •Hepatic function:
• •Total bilirubin \<1.5 × the upper limit of normal (ULN) Aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT), and alkaline phosphatase (ALP) ≤2.5 × ULN In patients with liver metastases: AST and ALT ≤5.0 × ULN In patients with liver and/or bone metastases: ALP ≤5.0 × ULN
• •Renal function:
• •Serum creatinine ≤1.5 × ULN Urine protein \<2+ on urinalysis; if baseline urine protein is ≥2+, a 24-hour urine protein ≤1.0 g is required
• •Coagulation function:
• •International normalized ratio (INR) ≤1.5 Activated partial thromboplastin time (aPTT) ≤1.5 × ULN
• •Cardiac function defined as left ventricular ejection fraction (LVEF) ≥50%.
• •Ability to communicate effectively with the investigator and to comply with study-related visits, treatment, laboratory tests, and other study requirements.
• •Participants meeting any of the following criteria will be excluded from the study:
• •Diagnosis of small cell lung cancer (SCLC), including mixed small cell and non-small cell lung cancer.
• •Presence of symptomatic brain metastases at the start of treatment.
• •Concurrent participation in another interventional clinical trial for cancer treatment.
• •History of tracheoesophageal fistula, gastrointestinal perforation, gastrointestinal fistula, or intra-abdominal abscess within 6 months prior to treatment initiation.
• •Presence of severe cardiovascular or cerebrovascular disease, including but not limited to:
• •Cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction, or significant vascular disease (including but not limited to aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to randomization; Unstable angina; Heart failure classified as New York Heart Association (NYHA) class ≥ II; Mean resting corrected QT interval (QTc) \>470 ms; Any clinically significant resting electrocardiogram (ECG) rhythm, conduction, or morphological abnormalities, such as complete left bundle branch block, third-degree atrioventricular (AV) block, second-degree AV block, or PR interval \>250 ms; Any factors that increase the risk of QTc prolongation or arrhythmic events, including heart failure, electrolyte abnormalities (serum/plasma potassium \< LLN; magnesium \< LLN; calcium \< LLN), congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death of a first-degree relative before the age of 40, or concomitant use of medications known to prolong the QT interval and induce torsades de pointes.
• •Major surgical procedures performed within 4 weeks prior to enrollment or planned during the study period.
• •Bleeding tendency, high risk of bleeding, or coagulation disorders, including thrombotic events within 6 months prior to randomization and/or history of hemoptysis within 3 months prior to randomization (defined as ≥2.5 mL per episode).
• •Presence of unhealed wounds, active gastrointestinal ulcers, or fractures (excluding healed historical fractures).
• •Known or suspected hypersensitivity to tislelizumab and/or any of its excipients.
• •Pregnant or breastfeeding women.
• •Women of childbearing potential or male participants who are unwilling to use effective contraception during the study and for 6 months after the last dose of study treatment.
• •Any other condition that, in the opinion of the investigator, would render the participant unsuitable for enrollment in this study.