Transthoracic vs Transbronchial Cryoablation for Early-stage Peripheral Lung Cancer

July 15, 2025 updated by: Jiayuan Sun

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

The study aims to compare the efficacy and safety of transthoracic cryoablation to transbronchial cryoablation in the treatment of early-stage peripheral lung cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Ablation therapy has been widely used in the treatment of peripheral lung cancer. Among various ablation techniques, cryoablation has been demonstrated to be therapeutic efficacy with several advantages, including high safety, clear ablation borders, and minimal local pain. With the development of navigational bronchoscopy, pilot study on transbronchial cryoablation for peripheral lung cancer has proved its efficacy and safety, but there is a lack of prospective randomized controlled trials to verify its near-term as well as long-term efficacy and safety. This study was designed as a prospective, randomized controlled, multicenter clinical trial. A total of 110 participants will be randomly assigned to either the transbronchial group or the transthoracic group in a 1:1 ratio. The primary endpoint is the complete ablation rate at 12 months post-ablation. Secondary endpoints include technical success rate, complete ablation rate at 6 months post-ablation, local control rate at 1, 2 and 3 years post-ablation, progression-free survival, overall survival, and safety.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jiayuan Sun, PhD
  • Phone Number: 1511 +86-021-22200000
  • Email: jysun1976@163.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Not yet recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
          • Shiyue Li, PhD
    • Henan
      • Zhengzhou, Henan, China, 462000
        • Not yet recruiting
        • Henan Provincial People's Hospital
        • Contact:
          • Xiaoju Zhang, PhD
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • West China Hospital, Sichuan University
        • Contact:
          • Dan Liu, PhD
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Not yet recruiting
        • Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
        • Contact:
          • Enguo Chen, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Transthoracic cryoablation
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
Transthoracic cryoablation will be performed under the guidance of CT.
Experimental: Transbronchial cryoablation
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
Transbronchial cryoablation will be performed under the guidance of navigation bronchoscopy and CBCT.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete ablation rate at 12 months
Time Frame: Twelve months post-ablation
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Technical success rate
Time Frame: Immediately after Each Operation
It is defined as the number of lesions for which the ablation needle reached the location of the lesion and was successfully ablated as a proportion of the total number of lesions to be ablated, as assessed by immediate post-ablation imaging
Immediately after Each Operation
Complete ablation rate at 6 months
Time Frame: Six months post-ablation
Six 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.
Six months post-ablation
Local control rates at 1, 2 and 3 years postoperatively
Time Frame: 12, 24, 36 monthspost-ablation
The number of lesions with complete and incomplete ablation at 1, 2, and 3 years after ablation treatment as a proportion of the number of all ablation-treated lesions.
12, 24, 36 monthspost-ablation
Progression-free survival (PFS)
Time Frame: From the time of treatment to the time of disease progression or death (determined by the one which occurs first), up to 36 months
PFS was defined from the first day after ablation to progression of target lesions and/or appearance of new lesions or death.
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）
Time Frame: From the time of treatment to the time of the patient death, up to 36 months
Overall survival（OS) is evaluated after the treatment of ablation until the patient death.
From the time of treatment to the time of the patient death, up to 36 months
Adverse event
Time Frame: Twelve months psot-ablation
All adverse events will be recorded during operation and during the follow-up, and be evaluated according to the CTCAE v5.0. Related and possible related AEs and SAEs will be determined and evaluated.
Twelve months psot-ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiayuan Sun

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jiayuan Sun, PhD, Shanghai Chest Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AT-RXLD-202401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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