Tianjin Medical University Cancer Institute and Hospital
Phase
Phase 2
Started
2025-04-01
Last updated
2025-04-22
Condition(s) studied
NSCLC (Non-small Cell Lung Cancer)
Investigational drug(s) / intervention(s)
Neoadjuvant Cryoablation Combined with Tislelizumab and ChemotherapySurgeryAdjuvant tislelizumab
Neoadjuvant Cryoablation Combined with Tislelizumab and Chemotherapy: Eligible patients will start the study treatment (7-14 days between pathological diagnosis and cryoablation). Patients first undergo cryoablation of the primary tumor. Then, 7±3 days after cryoablation, they start treatment with tislelizumab (200 mg) plus platinum-based doublet chemotherapy, given every 3 weeks for 3-4 cycles.
The following platinum-based doublet chemotherapy regimens are allowed in this trial:
* Cisplatin/carboplatin + pemetrexed (non-squamous NSCLC)
* Cisplatin/carboplatin + albumin-bound paclitaxel/paclitaxel (squamous NSCLC)
Surgery: After completing neoadjuvant therapy, surgery should be performed as soon as possible within 4-6 weeks after the last dose of neoadjuvant therapy.
Adjuvant tislelizumab: Patients receiving adjuvant therapy must meet the following criteria:
* ECOG performance status score of 0 or 1
* Recovery from surgery and adequate organ function as determined by the investigator based on laboratory values During the adjuvant phase, patients will receive tislelizumab as adjuvant therapy. The first dose of tislelizumab (cycle 1 of the adjuvant phase) should be administered within 2-8 weeks after surgery. Patients will continue to receive tislelizumab (400 mg, Q6W) as adjuvant therapy every 6 weeks until one of the following events occurs: completion of 8 cycles of tislelizumab adjuvant therapy, disease recurrence, unacceptable adverse events (AEs), death, or decision by the patient and/or investigator to discontinue study treatment.
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Pathological Complete Response (pCR) Rate — Up to approximately 8 weeks following completion of neoadjuvant treatment pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
Trial sites (1)
Facility
City
Region
Status
Tianjin Medical University Cancer Institute and Hospital
Tianjin
China
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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