NCT06939127RecruitingPhase 2
Cryoablation Combined With Tislelizumab and Chemotherapy as Neoadjuvant and Adjuvant Therapy in Resectable Stage II-IIIB NSCLC
A Prospective Phase II Study to Explore the Efficacy and Safety of Cryoablation Combined With Tislelizumab and Chemotherapy as Neoadjuvant Treatment, Followed by Adjuvant Tislelizumab Therapy in Resectable Stage II-IIIB Non-small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 22 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- First submitted
- 7 Apr 2025
- Start date
- 1 Apr 2025
- Primary completion date
- 31 May 2026
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Diseases
- Lung cancer
- NCT number
- NCT06939127
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 38
- From 1 Apr 2025 to the primary completion date, 31 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment for current lung cancer, including chemotherapy or radiotherapy.
- Hospitalization for severe infections within 4 weeks before enrollment. Systemic antibiotic treatment within 2 weeks before enrollment.
- Corticosteroid or immunosuppressive use within 14 days before enrollment, except for specific local, topical, or short-term uses.
Other illness
- 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.
- 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.
Lab values
- 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.
Other
- LCNEC diagnosis.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.