Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06939127

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

Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-04-22

38

Participants Needed

1

Research Sites

112 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China, 300000

Actively Recruiting

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Research Team

D

Donsheng Yue Chief Physician of Surgery

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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