Transthoracic vs Transbronchial Cryoablation for Early-stage Peripheral Lung Cancer

NCT06572540 | Recruiting

• 1 other identifier: AT-RXLD-202401
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 5

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.

Conditions

Lung Cancer

Keywords

Cryoablation; Lung cancer; Transbronchial ablation; Transthoracic ablation

Outcome Measures

Primary Outcomes (1)

• Complete ablation rate at 12 months

  Twelve months after the overall ablation procedure, the proportion that subjects whose lesion recevied ablation maintain completely ablated account for all evaluable subjects who receive cryoablation.

  Twelve months post-ablation

Secondary Outcomes (6)

• Technical success rate

  Immediately after Each Operation

• Complete ablation rate at 6 months

  Six months post-ablation

• Local control rates at 1, 2 and 3 years postoperatively

  12, 24, 36 monthspost-ablation

• Progression-free survival (PFS)

  From the time of treatment to the time of disease progression or death (determined by the one which occurs first), up to 36 months

• Overall survival（OS）

  From the time of treatment to the time of the patient death, up to 36 months

Study Arms (2)

Transthoracic cryoablation

ACTIVE COMPARATOR

Subjects will undergo CT-guided cryoablation. According to the location of the lesion on the chest CT scan, the puncture point, direction of needle entry, and distance of needle entry will be determined. The primary cryoablation needle (via the chest wall) will be punctured into the lesion according to the pre-planed path, and the CT will confirm the correct position. One or more needles will rationally distributed in the lesion for ablation according to the morphology of the lesion.

Device: Transthoracic cryoablation

Transbronchial cryoablation

EXPERIMENTAL

Subjects will undergo bronchoscopically guided cryoablation. Appropriate guided bronchoscopic technique will be uesd. Cryoablation needle (flexible) will insert through the working channel of the bronchoscope to the target lesion, CBCT will be used to confirm the correct position and observe the ablation zone.

Device: Transbronchial cryoablation

Interventions

Transthoracic cryoablation DEVICE

Transthoracic cryoablation will be performed under the guidance of CT.

Transthoracic cryoablation

Transbronchial cryoablation DEVICE

Transbronchial cryoablation will be performed under the guidance of navigation bronchoscopy and CBCT.

Transbronchial cryoablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age older than 18 years.
• Primary peripheral lung cancer diagnosed by pathology and pre-procedure staging examination suggesting clinical stage T1N0M0, stage IA (including postoperative new and multiple primary).
• The target lesion was evaluated to be feasible for both CT and bronchoscopy-guided ablation.
• Patients who are not suitable for surgery or refuse surgery, agree to undergo initial ablation therapy and sign informed consent form.

You may not qualify if:

• Patients with platelets \<70×109/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short term.
• Patients with severe pulmonary fibrosis and pulmonary arterial hypertension.
• 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.
• 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.
• Those with poorly controlled malignant pleural effusions.
• 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.
• Eastern Cooperative Oncology Group (ECOG) score \>2.
• Combination with other tumors with extensive metastases and an expected survival of \<6 months.
• Patients with episodic psychosis.
• Pregnant women, or patients with pregnancy plan during the study period.
• Have participated or are participating in other clinical studies within 30 days.
• Any other condition that the investigator considers inappropriate for participation in this study.

Sponsors & Collaborators

• Jiayuan Sun: lead

Study Sites (5)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

NOT YET RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 462000, 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, 610041, China

NOT YET RECRUITING

Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

NOT YET RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jiayuan Sun, PhD

  Shanghai Chest Hospital

  STUDY DIRECTOR

Central Study Contacts

Jiayuan Sun, PhD

CONTACT

+86-021-22200000; jysun1976@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Department of Respiratory Endoscopy

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 27, 2024
• Study Start: September 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)