Freezing small peripheral lung tumors through the chest versus through the airways

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized controlled trial will enroll 110 adults with primary peripheral stage IA (T1N0M0) lung cancer and randomize them 1:1 to transthoracic (CT-guided percutaneous) or transbronchial (navigational bronchoscopy-guided) cryoablation. The primary endpoint is the complete ablation rate at 12 months, and secondary endpoints include technical success, complete ablation at 6 months, local control at 1–3 years, progression-free survival, overall survival, and safety. Procedures build on prior pilot work showing feasibility of bronchoscopic cryoablation but will provide prospective randomized multicenter comparison data. The trial seeks to compare near-term and long-term efficacy and complications between the two approaches to inform treatment choices for patients ineligible for or refusing surgery.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting
• The First Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Not yet recruiting
• Henan Provincial People's Hospital
  Zhengzhou, Henan, China Not yet recruiting
• West China Hospital, Sichuan University
  Chengdu, Sichuan, China Not yet recruiting
• Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Not yet recruiting

Study contacts

• Study coordinator: Jiayuan Sun, PhD
• Email: jysun1976@163.com
• Phone: +86-021-22200000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.