NCT07528274招募中2 期
Microwave Ablation in Combination With Tislelizumab and Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer After Progression Following First-Line Immunotherapy Plus Chemotherapy: A Prospective, Single-Arm, Phase II Study
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Progression-free Survival
研究概览
简要总结
The purpose of this clinical trial is to evaluate progression-free survival (PFS) of microwave ablation in combination with tislelizumab and docetaxel in patients with advanced non-small cell lung cancer (NSCLC) who have progressed following first-line immunotherapy combined with chemotherapy.
Participants with advanced NSCLC who experienced disease progression after first-line immunotherapy plus chemotherapy will receive the following treatments:
- Tislelizumab: 200 mg administered intravenously every 3 weeks (Q3W)
- Docetaxel: 75 mg/m² administered intravenously every 3 weeks (Q3W) for 4-6 cycles
- Microwave ablation, administered per protocol
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cytologically or histologically confirmed non-small cell lung cancer (NSCLC), classified as stage IIIB, IIIC, or IV (AJCC 9th edition) and not eligible for curative treatment.
- •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.
排除标准
- •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.
研究组 & 干预措施
Microwave Ablation Plus Tislelizumab and Docetaxel
Experimental
Participants will receive microwave ablation in combination with tislelizumab and docetaxel following disease progression after first-line immunotherapy plus chemotherapy.
干预措施: Microwave ablation (Other)
Microwave Ablation Plus Tislelizumab and Docetaxel
Experimental
Participants will receive microwave ablation in combination with tislelizumab and docetaxel following disease progression after first-line immunotherapy plus chemotherapy.
干预措施: Docetaxel (Drug)
Microwave Ablation Plus Tislelizumab and Docetaxel
Experimental
Participants will receive microwave ablation in combination with tislelizumab and docetaxel following disease progression after first-line immunotherapy plus chemotherapy.
干预措施: Tislelizumab (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: Up to 2 years
PFS was defined as the time from enrollment to the first objectively documented disease progression as assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.
次要结局
- Objective Response Rate(up to 2 years)
- Overall Survival(up to 3 years)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(up to 2 years)
研究者
Tongguo Si
Dr.
Tianjin Medical University Cancer Institute and Hospital
研究点 (1)
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