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).
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;
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;
Single group
Multimodal Ablation
DeviceCT-guided preoperative multimodal ablation performed with multimodal tumor therapy system.Target lung lesions are ablated within 2 weeks after subject enrollment.
Neoadjuvant therapy
DrugNeoadjuvant tislelizumab (200 mg, IV, Q3W) combined with chemotherapy will be administered within 2 weeks after ablation. For patients with squamous NSCLC, cisplatin or carboplatin combined with paclitaxel will be used; for patients with non-squamous NSCLC, cisplatin or carboplatin combined with pemetrexed will be used, for a total of 3-4 cycles of treatment.
Surgery
Procedure/SurgerySurgical resection will be performed within 4-6 weeks after the last neoadjuvant treatment. The pulmonary lesions (including the ablated lesions) will be radically resected via surgery.
Adjunctive therapy
DrugAdjuvant therapy will be initiated within 2-8 weeks after surgery. Postoperative adjuvant therapy with tislelizumab (400 mg, Q6W) will be maintained for up to 1 year. Concomitant chemotherapy is allowed during this period based on guidelines/consensus or multidisciplinary team (MDT) discussion.
Pathological Complete Response Rate
Proportion of patients with no residual viable tumor cells in the resected primary tumor and all resected lymph nodes after completion of neoadjuvant therapy.
Major Pathological Response Rate
Proportion of patients with ≤10% residual viable tumor cells in the resected primary tumor and all resected lymph nodes after completion of neoadjuvant therapy. Assessed by pathologist within 2 weeks after surgical resection.
Event-Free Survival
Time from start of treatment to the first occurrence of any of the following events: disease progression precluding surgical treatment, local or distant recurrence, or death from any cause. Patients without an event are censored at the date of last imaging assessment.
Overall Survival
Time from enrollment to death due to any cause. Patients alive at last follow-up are censored at the last follow-up date. Lost-to-follow-up patients are censored at the last confirmed survival date.
Incidence and Severity of Adverse Events and Serious Adverse Events
Safety will be assessed by monitoring the incidence, type, and severity of adverse events (AEs) and serious adverse events (SAEs) graded according to NCI-CTCAE v6.0.
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