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
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
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.
• Deemed suitable for R0 resection by a thoracic surgeon for radical treatment.
• Adequate cardiopulmonary function for radical surgical resection.
• Eligible for cryoablation and platinum-based doublet chemotherapy.
• Adequate blood and organ function, as per laboratory tests within 14 days before enrollment.
Locations
Other Locations
China
Tianjin Medical University Cancer Institute and Hospital
RECRUITING
Tianjin
Contact Information
Primary
Donsheng Yue Chief Physician of Surgery
yuedongsheng_cg@163.com
+8602223109106
Time Frame
Start Date:2025-04-01
Estimated Completion Date:2027-05-31
Participants
Target number of participants:38
Treatments
Experimental: Cryoablation Combined with Tislelizumab
Neoadjuvant Phase:~Eligible 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.~Surgery should be performed as soon as possible within 4-6 weeks after the last dose of neoadjuvant therapy.~Adjuvant Phase:~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.