NCT06939127 Cryoablation Combined With Tislelizumab and Chemotherapy as Neoadjuvant and Adjuvant Therapy in Resectable Stage II-IIIB NSCLC
| NCT ID | NCT06939127 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Condition | NSCLC (Non-small Cell Lung Cancer) |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 38 participants in total. It began in 2025-04-01 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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.
Contact & Investigator
Dongsheng Yue Chief Physician of Surgery
PRINCIPAL INVESTIGATOR
Tianjin Medical University Cancer Institute and Hospital
Frequently Asked Questions
Who can join the NCT06939127 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying NSCLC (Non-small Cell Lung Cancer). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06939127 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06939127 currently recruiting?
Yes, NCT06939127 is actively recruiting participants. Contact the research team at yuedongsheng_cg@163.com for enrollment information.
Where is the NCT06939127 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06939127 clinical trial?
NCT06939127 is sponsored by Tianjin Medical University Cancer Institute and Hospital. The principal investigator is Dongsheng Yue Chief Physician of Surgery at Tianjin Medical University Cancer Institute and Hospital. The trial plans to enroll 38 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.