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Surgery combined with ablation for multiple pulmonary nodules: a prospective single arm multicenter clinical trial

Surgery combined with ablation for multiple pulmonary nodules: a prospective single arm multicenter clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105705
Enrollment
Unknown
Registered
2025-07-09
Start date
2025-06-10
Completion date
Unknown
Last updated
2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with multiple pulmonary nodules

Interventions

Test group:Surgical ablation

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Provide informed consent prior to any study specific procedures; 2. Between 18 and 75 years old (including 18 and 75 years old), both male and female; 3. Chest high-resolution CT showed that the main lesion was = 10mm, CTR>0.5, and the clinical evaluation was in line with the surgical pointer (lobectomy); 4. Chest high-resolution CT showed secondary lesions = 5mm, = 10mm, CTR= 1.5 × 10^9/L, platelet count (PLT) >= 100 × 10^9/L, hemoglobin (HB) >= 9g/dl; (Note: no blood transfusion or component blood or hematopoietic stimulating factor was used within 14 days before the first administration); b. Serum total bilirubin (TBIL) 1.5 × ULN, the calculated creatinine clearance (Cockcroft Gault formula) >= 50 ml/min.

Exclusion criteria

Exclusion criteria: 1. Patients with previous cancer history and pulmonary nodule metastasis were considered; 2. Any systemic anti-cancer treatment for pulmonary nodules before or after surgery, including chemotherapy, radiotherapy, cytotoxic drug therapy, targeted drug therapy (including tyrosine kinase inhibitors or monoclonal antibodies), and experimental treatment; 3. There were unresectable or metastatic diseases, pathological reports showed positive surgical margins or extranodal invasion under the microscope, or there were lesions left during the operation, or there were suspicious lesions determined by imaging after the operation; 4. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that began to attack within the last 3 months, congestive heart failure, myocardial infarction that occurred within 6 months before enrollment, serious arrhythmia requiring drug treatment, liver, kidney or metabolic diseases); 5. Previous history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring steroid treatment or any evidence of active interstitial lung disease; 6. Have a clear history of neurological or mental disorders, including epilepsy or dementia; Other researchers think it is not suitable to be enrolled.

Design outcomes

Primary

MeasureTime frame
disesease free survival;

Secondary

MeasureTime frame
Incidence and severity of complications;readmission rate;

Countries

China

Contacts

Public ContactHu Liao

West China Hospital of Sichuan University

drliaohu@scu.edu.cn+86 18980605130

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026