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Cryoablation Combined With Tislelizumab and Chemotherapy as Neoadjuvant and Adjuvant Therapy in Resectable Stage II-IIIB NSCLC | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT06939127•Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Aged ≥18 years at informed consent signing.
•ECOG performance status of 0 or 1.
•Histologically confirmed stage II-IIIB NSCLC (AJCC 9th edition).
•Tumor size ≤5 cm.
•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.

Exclusion Criteria

•Prior treatment for current lung cancer, including chemotherapy or radiotherapy.
•LCNEC diagnosis.
•Known EGFR mutations or ALK translocations. For non-squamous NSCLC, EGFR mutation status must be confirmed locally or centrally if unknown.
•For squamous NSCLC, EGFR testing is not required if status is unknown. ALK translocation testing is not required if status is unknown.
•Locally advanced, unresectable disease, regardless of stage or metastasis (stage IV). Patients with mediastinal lymph node involvement on CT must undergo sampling for clinical staging to exclude stage IIIB/C.
•History of interstitial lung disease, non-infectious pneumonitis, or uncontrolled pulmonary fibrosis.
•Severe chronic or active infections requiring systemic antimicrobials, including tuberculosis.
•Hospitalization for severe infections within 4 weeks before enrollment. Systemic antibiotic treatment within 2 weeks before enrollment.
•Active autoimmune disease or history of recurrent autoimmune disease.
•Exceptions: Well-controlled type 1 diabetes, hypothyroidism on hormone replacement, celiac disease, skin conditions not requiring systemic therapy, or diseases unlikely to recur without provocation.
+2 more criteria

Locations (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Key Dates

Start Date

April 1, 2025

Primary Completion Date

May 31, 2026

Completion Date

May 31, 2027

Last Updated

April 22, 2025

Enrollment

ESTIMATED participants

Conditions

NSCLC (Non-small Cell Lung Cancer)

Interventions

Neoadjuvant Cryoablation Combined with Tislelizumab and Chemotherapy

DRUG

Surgery

PROCEDURE

Adjuvant tislelizumab

DRUG

Contacts

Donsheng Yue Chief Physician of Surgery

CONTACT

+8602223109106 yuedongsheng_cg@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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