NCT06052098 Transbronchial vs Transthoracic Ablation for Early-stage Peripheral Lung Cancer
| NCT ID | NCT06052098 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hangzhou Broncus Medical Co., Ltd. |
| Condition | Stage IA Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2023-10-11 |
| Primary Completion | 2025-04 |
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 2023-10-11 with a primary completion date of 2025-04.
⚠ 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 purpose of this study is to investigate the efficacy and safety of RFA through a transthoracic or transbronchial approach in the treatment of early-stage peripheral lung cancer.
Eligibility Criteria
Inclusion Criteria: 1. Age greater than 18 years. 2. Primary peripheral lung cancer diagnosed by pathology, and preoperative staging reveals clinical stage T1N0M0, stage IA. 3. The planned ablation lesions are assessed to be amenable to CT-guided and bronchoscopy-guided ablation. 4. Assessed as inoperable or refused surgery, agree to undergo initial ablation therapy, and sign informed consent. Exclusion Criteria: 1. Patients with platelet \< 50 × 10 9/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short period of time. 2. Patients with severe pulmonary fibrosis and pulmonary hypertension. 3. Perilesional infection and radiation inflammation, puncture site skin infection is not well controlled, systemic infection, high fever \> 38.5℃. 4. Patients with severe liver, kidney, heart, lung and brain dysfunction, severe anemia, dehydration and severe nutritional metabolism disorders that cannot be corrected or improved in a short period of time. 5. Patients with poorly controlled malignant pleural effusion. 6. Anticoagulation therapy and/or antiplatelet agents (except novel oral anticoagulants such as dabigatran and rivaroxaban) are discontinued for less than 5\~7 days before ablation. 7. Eastern Cooperative Oncology Group (ECOG) score \> 2. 8. Combined with other tumors with extensive metastasis, expected survival \< 6 months. 9. Patients with episodic psychosis. 10. Patients with implantable electronic devices (such as pacemaker or defibrillator). 11. Pregnant women, or patients who have pregnancy plans during the study. 12. Participation or ongoing participation in another clinical study within the past 30 days. 13. Other situations that the investigator deems inappropriate to participate in this study.
Contact & Investigator
Jiayuan Sun, MD, PhD
PRINCIPAL INVESTIGATOR
Shanghai Chest Hospital
Frequently Asked Questions
Who can join the NCT06052098 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stage IA 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 NCT06052098 currently recruiting?
Yes, NCT06052098 is actively recruiting participants. Contact the research team at xkyyjysun@163.com for enrollment information.
Where is the NCT06052098 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06052098 clinical trial?
NCT06052098 is sponsored by Hangzhou Broncus Medical Co., Ltd.. The principal investigator is Jiayuan Sun, MD, PhD at Shanghai Chest Hospital. The trial plans to enroll 110 participants.
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