NCT06939127

Cryoablation Combined With Tislelizumab and Chemotherapy as Neoadjuvant and Adjuvant Therapy in Resectable Stage II-IIIB NSCLC

A Prospective Phase II Study to Explore the Efficacy and Safety of Cryoablation Combined With Tislelizumab and Chemotherapy as Neoadjuvant Treatment, Followed by Adjuvant Tislelizumab Therapy in Resectable Stage II-IIIB Non-small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II single-arm study designed to evaluate the efficacy and safety of cryoablation combined with tislelizumab and platinum-based doublet chemotherapy as neoadjuvant therapy, followed by adjuvant tislelizumab therapy in patients with resectable stage II-IIIB non-small cell lung cancer (NSCLC). The study consists of a screening phase, a treatment phase (including the neoadjuvant stage, surgery, and adjuvant stage), a safety follow-up period, and a survival follow-up period.

Conditions

• NSCLC (Non-small Cell Lung Cancer)

Interventions

Type	Name	Description
DRUG	Neoadjuvant Cryoablation Combined with Tislelizumab and Chemotherapy	Eligible patients will start the study treatment (7-14 days between pathological diagnosis and cryoablation). Patients first undergo cryoablation of the primary tumor. Then, 7±3 days after cryoablation, they start treatment with tislelizumab (200 mg) plus platinum-based doublet chemotherapy, given every 3 weeks for 3-4 cycles. The following platinum-based doublet chemotherapy regimens are allowed in this trial: * Cisplatin/carboplatin + pemetrexed (non-squamous NSCLC) * Cisplatin/carboplatin + albumin-bound paclitaxel/paclitaxel (squamous NSCLC)
PROCEDURE	Surgery	After completing neoadjuvant therapy, surgery should be performed as soon as possible within 4-6 weeks after the last dose of neoadjuvant therapy.
DRUG	Adjuvant tislelizumab	Patients receiving adjuvant therapy must meet the following criteria: * ECOG performance status score of 0 or 1 * Recovery from surgery and adequate organ function as determined by the investigator based on laboratory values During the adjuvant phase, patients will receive tislelizumab as adjuvant therapy. The first dose of tislelizumab (cycle 1 of the adjuvant phase) should be administered within 2-8 weeks after surgery. Patients will continue to receive tislelizumab (400 mg, Q6W) as adjuvant therapy every 6 weeks until one of the following events occurs: completion of 8 cycles of tislelizumab adjuvant therapy, disease recurrence, unacceptable adverse events (AEs), death, or decision by the patient and/or investigator to discontinue study treatment.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-05-31
• Completion: 2027-05-31
• First posted: 2025-04-22
• Last updated: 2025-04-22

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study