NCT06503744

Brief Summary

The aim of this study is to investigate the efficacy and safety of transthoracic versus transbronchial ablation in the treatment of early stage peripheral lung cancer.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
32mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Jan 2024Dec 2028

Study Start

First participant enrolled

January 4, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 16, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 13, 2026

Status Verified

May 1, 2025

Enrollment Period

2.9 years

First QC Date

July 10, 2024

Last Update Submit

April 6, 2026

Conditions

Lung Cancer Stage IA

Outcome Measures

Primary Outcomes (1)

  • Complete ablation rate at 6 months post-procedure

    This refers to the number of lesions completely ablated 6 months after ablative treatment as a proportion of the total number of ablative treated lesions.

    Up to 6 months

Secondary Outcomes (6)

  • Success rate of technique implementation

    Immediate postoperative

  • Complete ablation rate at 12 months post-procedure

    Up to 12 months

  • Local control rate at 1, 2 and 3 years post-procedure

    Up to 36 months

  • Progression-free survival

    Up to 36 months

  • Overall survival

    Up to 36 months

  • +1 more secondary outcomes

Study Arms (2)

Transthoracic ablation

ACTIVE COMPARATOR

Transthoracic ablation

Procedure: ablation

Transbronchial ablation

EXPERIMENTAL

Transbronchial ablation

Procedure: ablation

Interventions

ablationPROCEDURE

ablation

Transbronchial ablationTransthoracic ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater 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 proposed ablation lesion was evaluated for feasibility of CT and bronchoscopy-guided ablation treatment.
  • Consent to initial ablation therapy is given after assessment of unsuitability for surgery or refusal of surgery and signed informed consent form.

You may not qualify if:

  • Patients with platelets \<50×109/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in the 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 the 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 of other tumours with extensive metastases and an expected survival of \<6 months.
  • Patients with episodic psychosis.
  • Patients with implanted electronic devices (e.g. pacemakers or defibrillators).
  • Pregnant women, or patients with a pregnancy planned during the study period.
  • Have participated or are participating in other clinical studies within the last 30 days.
  • Any other condition that the investigator considers inappropriate for participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jiayuan Sun, PhD

    Shanghai Chest Hospital

    STUDY DIRECTOR

Central Study Contacts

Jiayuan Sun, PhD

CONTACT

+86-021-22200000jysun1976@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
PRINCIPAL INVESTIGATOR
PI Title
Director, Department of Respiratory Endoscopy

Study Record Dates

First Submitted

July 10, 2024

First Posted

July 16, 2024

Study Start

January 4, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2028

Last Updated

April 13, 2026

Record last verified: 2025-05

Locations

CN(1)