NCT06572540 Transthoracic vs Transbronchial Cryoablation for Early-stage Peripheral Lung Cancer
| NCT ID | NCT06572540 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jiayuan Sun |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2024-09-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study aims to compare the efficacy and safety of transthoracic cryoablation to transbronchial cryoablation in the treatment of early-stage peripheral lung cancer.
Eligibility Criteria
Inclusion Criteria: 1. Age older than 18 years. 2. Primary peripheral lung cancer diagnosed by pathology and pre-procedure staging examination suggesting clinical stage T1N0M0, stage IA (including postoperative new and multiple primary). 3. The target lesion was evaluated to be feasible for both CT and bronchoscopy-guided ablation. 4. Patients who are not suitable for surgery or refuse surgery, agree to undergo initial ablation therapy and sign informed consent form. Exclusion Criteria: 1. Patients with platelets \<70×109/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short term. 2. Patients with severe pulmonary fibrosis and pulmonary arterial hypertension. 3. Infectious and radioactive inflammation around the lesion, skin infection at the puncture site that is not well controlled, systemic infection, high fever \>38.5°C. 4. Patients with severe hepatic, renal, cardiac, pulmonary and cerebral insufficiency, severe anaemia, dehydration and serious disorders of nutritional metabolism that cannot be corrected or improved in a short term. 5. Those with poorly controlled malignant pleural effusions. 6. Anticoagulation therapy and/or anti-platelet drugs (except dabigatran, rivaroxaban and other new oral anticoagulants) have not been discontinued more than 5\~7d before ablation. 7. Eastern Cooperative Oncology Group (ECOG) score \>2. 8. Combination with other tumors with extensive metastases and an expected survival of \<6 months. 9. Patients with episodic psychosis. 10. Pregnant women, or patients with pregnancy plan during the study period. 11. Have participated or are participating in other clinical studies within 30 days. 12. Any other condition that the investigator considers inappropriate for participation in this study.
Contact & Investigator
Jiayuan Sun, PhD
STUDY DIRECTOR
Shanghai Chest Hospital
Frequently Asked Questions
Who can join the NCT06572540 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06572540 currently recruiting?
Yes, NCT06572540 is actively recruiting participants. Contact the research team at jysun1976@163.com for enrollment information.
Where is the NCT06572540 trial being conducted?
This trial is being conducted at Guangzhou, China, Zhengzhou, China, Shanghai, China, Chengdu, China and 1 additional location.
Who is sponsoring the NCT06572540 clinical trial?
NCT06572540 is sponsored by Jiayuan Sun. The principal investigator is Jiayuan Sun, PhD at Shanghai Chest Hospital. The trial plans to enroll 110 participants.
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