Multimodal Ablation Combined With Perioperative Tislelizumab and Chemotherapy for Resectable II-IIIB NSCLC

Starting soon · Phase 2

Conditions studied: NSCLC

In brief

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).

Key facts

Study ID

NCT07729670

Run by

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

People needed

42

Starts

2026-06-01

Expected to finish

2031-06-01

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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