Transbronchial vs Transthoracic Ablation for Early-stage Peripheral Lung Cancer

NCT06052098 | Recruiting

• 1 other identifier: BC-I-RF-01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage IA Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Complete ablation rate at 6 months after ablation

  It is defined as the proportion of lesions with complete ablation to all ablated lesions at 6 months after ablation.

  6 months

Secondary Outcomes (6)

• Technical success rate

  Immediately after ablation

• Complete ablation rate 12 months after ablation

  12 months

• Local control rate at 1 year, 2 years and 3 years after ablation

  1 year, 2 years and 3years

• Progression free survival (PFS)

  3 years

• Overall survival (OS)

  3 years

Study Arms (2)

Transbronchial group

EXPERIMENTAL

Subjects receive bronchoscopy-guided RFA and undergo follow-up.

Device: The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system

Transthoracic group

EXPERIMENTAL

Subjects receive CT-guided RFA and undergo follow-up.

Device: The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system

Interventions

The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system DEVICE

Procedure: In combination with guided bronchoscopy and CBCT, the ablation catheter is placed in the target lesion. CBCT confirms the tool in the lesion, adjusts the position of the ablation catheter, and monitors the extent of ablation.

Transbronchial group

The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system DEVICE

Procedure: The ablation needle is punctured into the lesion under CT guidance. The extent of the ablation is monitored by CT.

Transthoracic group

Eligibility Criteria

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

You may qualify if:

• Age greater than 18 years.
• Primary peripheral lung cancer diagnosed by pathology, and preoperative staging reveals clinical stage T1N0M0, stage IA.
• The planned ablation lesions are assessed to be amenable to CT-guided and bronchoscopy-guided ablation.
• Assessed as inoperable or refused surgery, agree to undergo initial ablation therapy, and sign informed consent.

You may not qualify if:

• Patients with platelet \< 50 × 10 9/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short period of time.
• Patients with severe pulmonary fibrosis and pulmonary hypertension.
• Perilesional infection and radiation inflammation, puncture site skin infection is not well controlled, systemic infection, high fever \> 38.5℃.
• 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.
• Patients with poorly controlled malignant pleural effusion.
• 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.
• Eastern Cooperative Oncology Group (ECOG) score \> 2.
• Combined with other tumors with extensive metastasis, expected survival \< 6 months.
• Patients with episodic psychosis.
• Patients with implantable electronic devices (such as pacemaker or defibrillator).
• Pregnant women, or patients who have pregnancy plans during the study.
• Participation or ongoing participation in another clinical study within the past 30 days.
• Other situations that the investigator deems inappropriate to participate in this study.

Sponsors & Collaborators

• Hangzhou Broncus Medical Co., Ltd.: lead
• Shanghai Chest Hospital: collaborator

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

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, MD, PhD

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiayuan Sun, MD, PhD

CONTACT

86-021-22200000; xkyyjysun@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: October 11, 2023
• Primary Completion: April 1, 2025
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)