Status:
RECRUITING
Cryoablation Combined With Tislelizumab and Chemotherapy as Neoadjuvant and Adjuvant Therapy in Resectable Stage II-IIIB NSCLC
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
NSCLC (Non-small Cell Lung Cancer)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT06939127
Start Date
April 1 2025
End Date
May 31 2027
Last Update
April 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China, 300000