Study summary
What is this study about? This clinical trial aims to compare two treatments for high-risk lung nodules or early-stage lung cancer: interventional ablation (a minimally invasive procedure that destroys tumors with heat or cold) and surgical resection (surgery to remove the tumor). The goal is to determine if ablation is as safe and effective as surgery while preserving more lung function.
Why is this important? Lung cancer is a leading cause of cancer deaths worldwide. Early detection improves survival, but surgery can damage lung function.
Ablation (e.g., microwave, cryotherapy) is less invasive than surgery and may offer similar outcomes with faster recovery. However, more evidence is needed to confirm its role in early-stage disease.
Eligibility
Inclusion Criteria:
1. Age of 20-79 years;
2. Eastern Cooperative Oncology Group Physical Status (ECOG PS) score of 0-2;
3. Enhanced CT of the chest: suspicious malignant signs of lung nodules, such as lobar sign, burr sign, pleural depression sign, bronchial insufflation sign, vacuolar sign, vascular cluster sign, or signs of twisted dilatation of blood vessels within the nodule and cystic cavity type, with no more than 3 lesions bilaterally or unilaterally, and no lymph node metastasis;
4. Thin-section CT of the chest: maximum diameter of the lesion \> 5mm ≤ 2cm, solid/tumour ratio CTR ≤ 0.25;
5. Adequate haematological, renal and hepatic functions:
1. Haematology: absolute neutrophil count (ANC) ≥1.5×109/L, platelet (PLT) ≥100×109/L, haemoglobin (HGB) ≥9 g/dL;
2. Liver function: serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤2.5 times the ULN, serum albumin (ALB) ≥2.8 g/dL;
3. Renal function: serum creatinine (Cr) ≤ 1.5 x ULN, or creatinine clearance ≥ 40 mL/min;
6. Subjects and subject sexual partners are required to use a medically approved contraceptive method (e.g., IUD, birth control pills, or condoms, etc.) during the study treatment period and for 6 months after the end of the study treatment period; (7) Subjects must sign a written informed consent form approved by the IRB/IEC in accordance with competent authorities and study site guidelines, and be able to comply with protocol-specified visits, treatment regimens, laboratory investigations, and related procedures.
Haematology Neutrophils (ANC) ≥1.5 x 109/L Platelets (PLT) ≥100×109/L Haemoglobin (Hb) ≥90g/L Liver Function Total bilirubin (TBIL) ≤1.5 x upper limit of normal (ULN) Glutamate aminotransferase (ALT) ≤2.5 × ULN; for patients with liver metastases ≤5 × ULN; Aspartate aminotransferase (AST) ≤2.5 x ULN; for patients with liver metastases ≤5 x ULN; Renal function Creatinine (Cr) ≤1.5×ULN; if \>1.5×ULN, creatinine clearance ≥50 mL/min (calculated according to the Cockcroft-Gault formula) Coagulation Activated partial thromboplastin time (APTT) ≤1.5×ULN Prothrombin time (PT) or International Normalised Ratio (INR) ≤1.5 x ULN
Exclusion Criteria:
1. Nodule adjacent to or encircling a large mediastinal vessel (e.g., aorta, superior vena cava, main pulmonary artery, main pulmonary vein, etc.), with a distance from the vessel \<5 mm;
2. Subpleural nodules (\<5 mm from the pleura);
3. patients with regional lymph node metastasis or distant metastasis confirmed by chest enhanced CT/HRCT;
4. patients with severe bleeding tendency, coagulation dysfunction that cannot be corrected within a short period of time (prothrombin time \>18 s, prothrombin activity \<40%) and/or platelet count \<50 × 109/L;
5. severe interstitial pneumonia, severe pulmonary fibrosis or severe emphysema;
6. malignant pleural effusion;
7. treatment for the following:
* received systemic anti-tumour therapy such as chemotherapy, targeted therapy, immunotherapy, etc;
* Received any investigational drug therapy;
* High dose immunosuppressive drugs (systemic glucocorticoids greater than 10mg/day prednisone or its equivalent) within 4 weeks prior to the entry assessment;
* Received a live attenuated vaccine within 4 weeks prior to the entry assessment (or plan to receive a live attenuated vaccine during the study period);
* Major surgery (e.g., open heart, open chest, or open abdomen) or unhealed surgical wounds, ulcers, or fractures within 4 weeks prior to the enrolment assessment;
8. Have another uncontrolled serious medical condition, including but not limited to:
* Serious infections that are active or not well controlled clinically;
* HIV infected (HIV antibody positive);
* Acute or chronic active hepatitis B (HBV DNA positive) or acute or chronic active hepatitis C (HCV antibody positive);
* Active tuberculosis, etc;
* Class III-IV congestive heart failure (New York Heart Association classification) with poorly controlled and clinically significant arrhythmias;
* Uncontrolled arterial hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg);
* Any arterial thrombosis, embolism or ischaemia such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischaemic attack within 6 months prior to enrolment for treatment;
* Diseases requiring anticoagulant therapy with Favalin (Coumadin);
* Uncontrolled hypercalcaemia (greater than 1.5 mmol/L Ca2+ or calcium greater than 12 mg/dL or corrected serum calcium greater than ULN) or symptomatic hypercalcaemia requiring continued bisphosphonate therapy;
* concomitant other malignancies (except those that have been eradicated, e.g., carcinoma in situ of the uterine cervix, non-melanoma skin cancer, etc.); and
9. Other acute or chronic medical conditions, psychiatric disorders, or abnormal laboratory test values that may result in: increased risk associated with study participation or administration of study medication, or interference with the interpretation of study results, and that, in the investigator's judgement, classifies the patient as ineligible for participation in this study;
10. Pregnant or lactating females.