Lung cancer
Conditions
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: •Peripulmonary solid or subsolid nodules that have been cytologically or histologically confirmed as non-small cell lung cancer and the patient is assessed as unsuitable for surgery; •Whole-body imaging assessment for cTNM stage I, including IA and IB stages, i.e., cT1N0M0~cT2aN0M0; Imaging evaluation methods include: chest CT with contrast, brain with contrast MR (or brain with contrast CT), abdominal color ultrasound (hepatobiliary, pancreatic and spleen, both adrenal glands and pelvis), whole body bone scan and superficial lymph node color ultrasound, or whole body PET-CT and brain contrast MR (or brain contrast CT); If pulmonary and mediastinal lymphadenopathy is shown by chest CT and PET-CT, EBUS is added to rule out lung and mediastinal lymph node metastasis. •Eastern Cooperative Oncology Group Performance Status (ECOG) score 0 to 2; •New York Heart Association (NYHA) Cardiac Function Class I-III; •Laboratory and auxiliary examination indicators are as follows: neutrophil count>1500/mm^3; Platelet count> 100000/mm^3; creatinine clearance >45ml/min; total bilirubin = 18 years; • Informed consent in accordance with ICH-GCP principles. •Left ventricular ejection fraction > 50 percent or within normal; •Pulmonary function (volume and diffusion) assessment suggests ablation minimum: FEV1/Pred > = 30 percent (ie, COPD-GOLD grade =40%.
Exclusion criteria
Exclusion criteria: Exclusion Criteria (General): Presence of factors that may affect the procedure or ablation treatment (e.g., moderate to severe pulmonary dysfunction, coagulation disorders, immune system diseases, etc.). Abnormal coagulation function (PT > 16 s, APTT > 43 s, TT > 21 s, Fbg = Grade 2 CTCAE within 4 weeks prior to visit; bleeding in other sites >= Grade 3 CTCAE within 4 weeks prior to visit. Thromboembolic events (arterial or venous) within 3 months prior to visit, cerebrovascular accident (including transient ischemic attack, new cerebral infarction within 6 months), pulmonary embolism, etc. Patients receiving anticoagulant or vitamin K antagonist therapy such as warfarin, heparin or its analogs; low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (daily dosage between 80 mg and 100 mg) for prophylactic purposes is allowed if the international normalized ratio (INR) of prothrombin time is =2 cm or CTR .= 0.5. Exclusion Criteria (Percutaneous CT-guided Ablation): Presence of other contraindications to ablation (e.g., significant infection along the ablation pathway and in the surgical area skin). Severe interstitial lung disease with severe reduction in diffusion function shown by pulmonary function tests (DLCO-SB/Pred < 50%). Lesions located in special anatomical sites affecting the safety of puncture, such as: lesions adjacent to large blood vessels or with blood vessels passing through the lesion, lesions located at the lung apex or lung base, and blood vessels difficult to avoid along the puncture pathway.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year event free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Local failure free survial;Safety;Overall survival;Ablation success rate; | — |
Countries
China
Contacts
Public ContactRen Shengxiang
Shanghai Pulmonary Hospital
Outcome results
None listed