NCT07729670尚未招募2 期
Multimodal Ablation Combined With Perioperative Tislelizumab and Chemotherapy for Resectable II-IIIB NSCLC
Cancer Institute and Hospital, Chinese Academy of Medical Sciences0 个研究点目标入组 42 人开始时间: 2026年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 42
- 主要终点
- Pathological Complete Response Rate
研究概览
简要总结
This is a prospective, open-label, single-center, single-arm phase II clinical trial evaluating the efficacy and safety of multimodal ablation in combination with perioperative tislelizumab and chemotherapy in patients with pathologically confirmed resectable stage II-IIIB (N2) non-small cell lung cancer (NSCLC).
详细描述
Eligible patients will receive multimodal ablation, followed by perioperative tislelizumab in combination with platinum-based doublet chemotherapy, and subsequently undergo radical surgical resection. Adjuvant tislelizumab will be continued after surgery.The primary endpoint is the pathological complete response (pCR) rate. Secondary endpoints include major pathological response (MPR) rate, event-free survival (EFS), overall survival (OS), and safety.
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
- •Age >= 18 years, either gender;
- •Pathologically confirmed stage II-IIIB (N2) squamous or non-squamous non-small cell lung cancer (NSCLC) according to the 9th edition of the AJCC/UICC NSCLC staging system;
- •Presence of lesions suitable for ablation therapy confirmed by imaging evaluation;
- •Evaluated as resectable with R0 resection before enrollment, and consent to undergo radical surgical resection;
- •ECOG performance status score of 0-1;
- •Eligible for platinum-based doublet chemotherapy;
- •Adequate cardiopulmonary function to meet the requirements of curative surgical resection;
- •Sufficient organ function confirmed by laboratory tests within 28 days before enrollment:
- •Blood routine: WBC >= 3.0×10^9/L; ANC >= 1.5×10^9/L; PLT >= 100×10^9/L; HGB >= 90 g/L.
- •Liver function: AST <= 5.0×ULN; ALT <= 5.0×ULN; TBIL <= 1.5×ULN;
- •Renal function: Cr <= 1.5×ULN;
- •For patients receiving cisplatin: creatinine clearance >= 60 mL/min.
- •For patients receiving carboplatin: creatinine clearance >= 45 mL/min.
- •Coagulation function: INR <= 1.5×ULN (<=3×ULN for patients on anticoagulants; anticoagulants must be discontinued for one week before ablation); APTT <= 1.5×ULN;
- •Fully understand the study and voluntarily sign the informed consent form (ICF).
排除标准
- •Tumor is adjacent to the hilum, invades major blood vessels, or has contraindications for surgery;
- •History of interstitial lung disease, non-infectious pneumonia, or uncontrolled pulmonary diseases including pulmonary fibrosis and acute lung disease;
- •Previous allogeneic stem cell transplantation or organ transplantation;
- •Previous radiotherapy or chemotherapy;
- •Previous local treatment (e.g., radioactive seed implantation, ablation) for the target ablation lesion;
- •Previous treatment with immune checkpoint inhibitors, including but not limited to anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies;
- •Complicated with severe cardiac, pulmonary, hepatic, renal insufficiency, or coagulation disorders;
- •Clinically significant cardio-cerebrovascular diseases, including but not limited to acute myocardial infarction within 6 months before enrollment, heart failure of NYHA class III or IV, ventricular arrhythmia ≥ grade 2, any history of cerebrovascular accident;
- •Underwent any major surgical procedure requiring general anesthesia within 28 days before enrollment;
- •Previous severe immune system diseases or active infection;
- •Pregnant or lactating female;
- •Complicated with other malignancies (un cured within 5 years);
- •Confirmed positive EGFR or ALK driver genes by genetic testing;
- •Any condition requiring systemic therapy with corticosteroids (>10 mg prednisone per day or equivalent) or other immunosuppressive drugs before enrollment;
- •Severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis;
- •Known history of HIV infection;
- •Untreated chronic hepatitis B patients, chronic hepatitis B virus (HBV) carriers with HBV DNA ≥ 500 IU/mL, or active hepatitis C virus (HCV) patients; (Note: Inactive hepatitis B surface antigen carriers, treated and stable hepatitis B patients (HBV DNA < 500 IU/mL), and cured hepatitis C patients are eligible.);
- •Received live vaccine within 28 days before enrollment;
- •Simultaneously participating in another therapeutic clinical study;
- •Other conditions considered unsuitable for participation in this study by the investigator.
结局指标
主要结局
Pathological Complete Response Rate
时间窗: Perioperative
Proportion of patients with no residual viable tumor cells in the resected primary tumor and all resected lymph nodes after completion of neoadjuvant therapy.
次要结局
- Major Pathological Response Rate(Perioperative)
- Event-Free Survival(Through study completion, up to 5 years)
- Overall Survival(Through study completion, up to 5 years)
- Incidence and Severity of Adverse Events and Serious Adverse Events(Through study completion)
研究者
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