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

PHASE2RecruitingINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

April 1, 2025

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2027

Conditions
NSCLC (Non-small Cell Lung Cancer)
Interventions
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."

Trial Locations (1)

300000

RECRUITING

Tianjin Medical University Cancer Institute and Hospital, Tianjin

All Listed Sponsors
lead

Tianjin Medical University Cancer Institute and Hospital

OTHER