Cryoablation Combined With Tislelizumab and Chemotherapy as Neoadjuvant and Adjuvant Therapy in Resectable Stage II-IIIB NSCLC
Recruiting · NCT06939127 · Interventional (participants receive a specific treatment) · Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Adjuvant tislelizumabNeoadjuvant Cryoablation Combined with Tislelizumab and ChemotherapySurgery
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Tianjin Medical University Cancer Institute and Hospital - Tianjin, China