Lung Cancer Stage IANCT06503744
Transthoracic vs Transbronchial Radiofrequency Ablation for Lung Cancer
A study testing ablation in people with Lung Cancer Stage IA, run by Shanghai Chest Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer Stage IA
- What is being tested?
- ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2024to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Jiayuan Sun, PhD, +86-021-22200000 ext. 1511, jysun1976@163.com
About this study
Official title: Transthoracic Versus Transbronchial Radiofrequency Ablation for Peripheral Lung Cancer Staging IA: a Prospective, Randomized Controlled Trial
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.
Read the detailed description
Ablation therapy has been widely used in the treatment of lung cancer and traditionally performed by CT-guided transthoracic puncture. In recent years, with the development of navigational bronchoscopy, exploratory studies on transbronchial ablation for peripheral lung cancer have demonstrated its efficacy and safety, but there is a lack of prospective randomized controlled trials to verify its near-term efficacy and safety, as well as its long-term efficacy. This study was designed as a prospective randomised controlled trial with 110 patients expected to participate in the study, randomized in a 1:1 ratio to CT-guided ablation and bronchoscopy-guided ablation treatment groups. The primary study endpoint is the rate of complete ablation at 6 months post-procedure. Secondary study endpoints were success rate of technique implementation, complete ablation rate at 12 months post-procedure, local control rate at 1, 2 and 3 years post-procedure, progression-free survival, overall survival and safety.
- Conditions
- Lung Cancer Stage IA
- Being tested
- ablation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ablationProcedure or surgery
ablation
| Study group | Role | What they receive |
|---|---|---|
| Transthoracic ablation | Active comparator | Transthoracic ablation Receives: Procedure: ablation |
| Transbronchial ablation | Experimental | Transbronchial ablation Receives: Procedure: ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months
Secondary outcomes (6)
Success rate of technique implementation
Defined as the number of lesions reached by the ablation needle and successfully treated by ablation as a proportion of the total number of lesions to be ablated, as assessed by imaging immediately after ablation.
Measured: Immediate postoperative
Complete ablation rate at 12 months post-procedure
This refers to the number of lesions completely ablated 12 months after ablative treatment as a proportion of the total number of ablative treated lesions.
Measured: Up to 12 months
Local control rate at 1, 2 and 3 years post-procedure
This refers to the number of completely ablated and incompletely ablated lesions at 1, 2 and 3 years after ablative treatment as a proportion of the total number of ablative treated lesions.
Measured: Up to 36 months
Progression-free survival
Refers to the duration between the subject's study procedure and the first occurrence of disease progression or death from any cause, recorded through follow-up for up to 3 years.
Measured: Up to 36 months
Overall survival
Refers to the duration between the subject's study procedure and the subject's death, recorded through follow-up for up to 3 years.
Measured: Up to 36 months
Incidence of complications
Assessment of the incidence of device or procedure-related adverse events that occurred during the study.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start4 Jan 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer Stage IAStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, Beijing Chao Yang Hospital
- Responsible party
- Principal investigator, Jiayuan Sun, Shanghai Chest Hospital
- Investigators
- Jiayuan Sun, PhD, Study director, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503744
- Sponsor's protocol ID
- SHCHE202301
- Status last verified
- May 2025
- First submitted
- 10 Jul 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transthoracic Versus Transbronchial Radiofrequency Ablation for Peripheral Lung Cancer Staging IA: a Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06503744
- Acronym / sponsor ID
- SHCHE202301
- Conditions
- Lung Cancer Stage IA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, Beijing Chao Yang Hospital
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Ablation therapy has been widely used in the treatment of lung cancer and traditionally performed by CT-guided transthoracic puncture. In recent years, with the development of navigational bronchoscopy, exploratory studies on transbronchial ablation for peripheral lung cancer have demonstrated its efficacy and safety, but there is a lack of prospective randomized controlled trials to verify its near-term efficacy and safety, as well as its long-term efficacy. This study was designed as a prospective randomised controlled trial with 110 patients expected to participate in the study, randomized in a 1:1 ratio to CT-guided ablation and bronchoscopy-guided ablation treatment groups. The primary study endpoint is the rate of complete ablation at 6 months post-procedure. Secondary study endpoints were success rate of technique implementation, complete ablation rate at 12 months post-procedure, local control rate at 1, 2 and 3 years post-procedure, progression-free survival, overall survival and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transthoracic ablation | Active comparator | Procedure: ablationTransthoracic ablation |
| Transbronchial ablation | Experimental | Procedure: ablationTransbronchial ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ablationablation | Procedure or surgery | Transbronchial ablation, Transthoracic ablation |
Primary outcome
Complete ablation rate at 6 months post-procedure
Time frame: Up to 6 months
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.
6 secondary outcomes
Success rate of technique implementation
Time frame: Immediate postoperative
Complete ablation rate at 12 months post-procedure
Time frame: Up to 12 months
Local control rate at 1, 2 and 3 years post-procedure
Time frame: Up to 36 months
Progression-free survival
Time frame: Up to 36 months
Overall survival
Time frame: Up to 36 months
Incidence of complications
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiayuan Sun, PhD study director
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ablation in people with Lung Cancer Stage IA, run by Shanghai Chest Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiayuan Sun, PhD (+86-021-22200000 ext. 1511, jysun1976@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete ablation rate at 6 months post-procedure (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.