Cryoablation with Tislelizumab and Chemotherapy for Non-small Cell Lung Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II study evaluates the safety and efficacy of combining cryoablation with tislelizumab and platinum-based chemotherapy as neoadjuvant therapy for patients with resectable stage II-IIIB non-small cell lung cancer (NSCLC). Participants will undergo a screening phase followed by a treatment phase that includes neoadjuvant therapy, surgery, and adjuvant therapy with tislelizumab. The study aims to assess the pathological complete response and overall survival outcomes. Safety and survival follow-up periods will also be included to monitor long-term effects.

Why it matters

Who can join: the full rules

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.
* Severe infections requiring systemic treatment within the past 4 weeks.
* Corticosteroid or immunosuppressive use within 14 days before enrollment, except for specific local, topical, or short-term uses.

Where it's running

• Tianjin Medical University Cancer Institute and Hospital
  Tianjin, China Recruiting

Study contacts

• Principal investigator: Dongsheng Yue Chief Physician of Surgery — Tianjin Medical University Cancer Institute and Hospital
• Study coordinator: Donsheng Yue Chief Physician of Surgery
• Email: yuedongsheng_cg@163.com
• Phone: +8602223109106

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Neoadjuvant therapy for locally advanced low rectal cancer: adding fruquintinib to short-course radiotherapy with tislelizumab and CAPOX

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.