non-small cell lung carcinoma
Conditions
Interventions
Treatment group:Tislelizumab Combined with Microwave Ablation for the Treatment of Stage I Non-Small Cell Lung Cancer
Sponsors
Shanghai Geriatric Medical Center
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1.Disease-Related Inclusion Criteria:; 1. Histologically or cytologically confirmed stage I NSCLC (T = 4 cm) based on the AJCC 9th edition staging system. 2. Patients who are ineligible for or have refused surgery and SBRT. 3. Pulmonary nodule with a solid component ratio (CTR) > 0.5. 4. ECOG performance status (PS): 0-2. 5. Expected survival of greater than 3 months. 2.Hematological, Biochemical, and Organ Function Criteria:; 1. Absolute neutrophil count (ANC) >= 1.5 x 10?/L, platelets >= 100 x 10?/L, hemoglobin >= 90 g/L. 2. International normalized ratio (INR) or prothrombin time (PT) =18 years at the time of signing the ICF.
Exclusion criteria
Exclusion criteria: 1.Disease-Related Exclusion Criteria:; 1. Patients who have previously received systemic anti-tumor therapy. 2. Patients who have received other approved systemic anti-cancer treatments or systemic immunomodulators (including but not limited to interferon, interleukin-2, and tumor necrosis factor) within 4 weeks prior to the first dose. 2.Study Drug-Related Exclusion Criteria:; 1. Known allergy to any investigational drug or its excipients. 2. Creatinine clearance < 45 mL/min. 3. Patients with active viral hepatitis requiring treatment, as determined by the investigator. 4. Patients with active autoimmune diseases requiring systemic treatment, or conditions assessed by the investigator to potentially interfere with study treatment. 5. Patients with long-term use of high-dose steroids or other immunosuppressants, which the investigator deems to potentially interfere with study treatment. 6. Patients with severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral treatment, including but not limited to tuberculosis infections: (a) Severe infection requiring hospitalization within 4 weeks prior to the first dose, including but not limited to infection-related complications, bacteremia, or severe pneumonia. (b) Receipt of oral or intravenous antibiotics within 2 weeks prior to the first dose. 3.General Exclusion Criteria:; 1. History of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases, including but not limited to diabetes mellitus, hypertension, pulmonary fibrosis, and acute pulmonary diseases. 2. Any major surgery requiring general anesthesia performed =28 days prior to the first dose. 3. Presence of baseline medical conditions or alcohol/drug abuse or dependence that could interfere with the administration of study drugs, impact result interpretation, or pose a high risk of treatment complications. 4. Concurrent participation in another interventional clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 year EFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event free survival, EFS;Overall Survival, OS;safety;Event free survival, EFS; | — |
Countries
China
Contacts
Public ContactJie Hu
Zhongshan Hospital, Fudan University
Outcome results
None listed