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

Transthoracic Versus Transbronchial Cryoablation for Early-stage Peripheral Lung Cancer: A Prospective, Randomized Controlled Trial

This trial will test whether freezing small peripheral lung tumors through the chest or through the airways works better and is safer for adults with early-stage lung cancer who can't or won't have surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Chest Hospital (Academic / other)
• Locations: 5 sites (Guangzhou, Guangdong and 4 other locations)
• Trial ID: NCT06572540 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults over 18 with pathologically confirmed primary peripheral stage IA (T1N0M0) lung cancer whose lesion is feasible for both CT- and bronchoscopy-guided ablation and who are not suitable for or refuse surgery.

Not a fit: Patients with advanced or central tumors, lesions not reachable by both CT and bronchoscopy, or with severe coagulopathy, uncontrolled infection, or major organ failure are unlikely to benefit from this comparison.

Why it matters

Potential benefit: If successful, the transbronchial approach could offer similar tumor control with fewer chest-wall complications, less pain, and a less invasive option than transthoracic cryoablation.

How similar studies have performed: Small pilot and single-center studies of transbronchial cryoablation have reported promising safety and efficacy, but randomized multicenter evidence is currently lacking.

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.

Where this trial is running

Guangzhou, Guangdong and 4 other locations

• 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)
• Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (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

Conditions Lung Cancer; Cryoablation; Lung cancer; Transbronchial ablation; Transthoracic ablation