CopdNCT06929390
Comparing BTVA and MWA in COPD With Early Lung Cancer: Efficacy and Safety
A study testing BTVA and MWA in people with Copd and Lung Cancer, run by Henan Provincial People's Hospital.
Trial summary
Based on the advantages of BTVA in the treatment of early-stage lung cancer and COPD, researchers propose the concept of using BTVA to treat COPD combined with early-stage lung cancer. Researchers plan to conduct a multicenter clinical study focusing on patients with COPD combined with malignant GGNs. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Copd, Lung Cancer
- What is being tested?
- BTVA and MWA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 31 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects meeting all of the following criteria are eligible for inclusion:
- Patients of any gender aged between 35 and 80 years with a diagnosis of chronic obstructive pulmonary disease (COPD);
- Chest CT showing ground-glass nodules (GGNs) with a solid/tumor ratio (CTR) ≤ 0.25;
- Nodule size < 2cm located in the upper lobes of both lungs;
- Pathologically diagnosed as primary peripheral lung cancer, with preoperative clinical staging indicating T1a, bN0M0;
- Investigator assessment that ablative techniques can be feasibly implemented via bronchoscopic or percutaneous approaches to reach the lesion;
- Patients unable to undergo surgery or refuse surgery and are unwilling or intolerant to radiation or chemotherapy;
- Signing an informed consent form, understanding, and actively cooperating with follow-up procedures
Who cannot join
- Subjects meeting any of the following conditions are ineligible for inclusion:
- Bronchoscopy contraindications, such as:
- Myocardial infarction within the past month, unstable myocardial ischemia, ejection fraction (EF) ≤40%
- Active hemoptysis
- Coagulation disorders
- Severe hepatic, renal, cardiac, pulmonary, or cerebral dysfunction, severe anemia, dehydration, and severe nutritional disturbances that cannot be corrected or improved in the short term
Show all 19Show fewer
- Pulmonary function reports indicating FEV1 ≤ 20% predicted value, or DLCO ≤ 20%;
- Respiratory tract infection or acute exacerbation of chronic obstructive pulmonary disease within the preceding 6 weeks before screening;
- Presence of large bullae in the lobe containing the target lung segment/subsegment (defined as bullae occupying more than 1/3 of the lobe) or paraseptal emphysema;
- High-density emphysematous changes simultaneously present in the upper and lower lobes of the contralateral lung, defined as HRCT showing low attenuation areas (<-950 HU) comprising more than 40% of the total lung volume;
- Tumor located within 2cm of the trachea, main bronchi, esophagus, aortic arch branches, main pulmonary artery, left and right pulmonary arteries, or heart, and within 1cm of the nearest pleural boundary;
- Active pathogenic infection or evidence of active infection (e.g., fever, elevated white cell count), poorly controlled infectious or inflammatory conditions around the lesion or at the puncture site;
- Discontinuation of anticoagulant and/or antiplatelet medications (excluding new oral anticoagulants such as dabigatran, rivaroxaban) for less than 5-7 days before surgery;
- Coexisting conditions or medication use increasing the risk of post-treatment complications, including but not limited to: autoimmune disorders, clinically significant immunosuppressants, history of asthma, α-1 antitrypsin deficiency;
- Daily prednisolone intake exceeding 10mg or an equivalent dose of glucocorticoids during the screening visit;
- History of cardiac or pulmonary transplantation, surgical lung volume reduction, median sternotomy, endoscopic lung volume reduction (e.g., valves, coils), lobectomy, or lung resection;
- Eastern Cooperative Oncology Group (ECOG) score >2;
- Participation in or currently involved in other clinical studies within the past 30 days;
- Other conditions deemed unsuitable for participation by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Clinical Trial Comparing Bronchoscopic Thermal Vapor Ablation and Percutaneous Microwave Ablation in Patients With COPD and Early-Stage Lung Cancer: Efficacy and Safety Evaluation
Based on the advantages of BTVA in the treatment of early-stage lung cancer and COPD, researchers propose the concept of using BTVA to treat COPD combined with early-stage lung cancer. Researchers plan to conduct a multicenter clinical study focusing on patients with COPD combined with malignant GGNs. Bronchoscopic BTVA surgery or percutaneous MWA surgery will be performed, evaluating the effectiveness and safety of bronchoscopic BTVA and percutaneous MWA surgery in the treatment of COPD combined with early-stage lung cancer.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a common respiratory disease, affecting nearly 100 million people in China, with the highest mortality rate globally. It is strongly associated with lung cancer, as both share risk factors such as tobacco exposure and environmental pollution. Additionally, chronic inflammation and abnormal repair mechanisms in COPD further increase the risk of lung cancer. Early diagnosis and treatment of lung cancer are crucial, particularly in detecting pulmonary nodules (GGN). Although malignant GGNs progress slowly, early surgical resection remains the best curative option. However, COPD patients face high surgical risks and should carefully consider their treatment options.
Microwave ablation (MWA) has been widely used as a local treatment for early-stage lung cancer, showing similar efficacy to surgery. However, percutaneous procedures may lead to complications such as pneumothorax and bleeding. In contrast, bronchoscopic thermal vapor ablation (BTVA), performed under general anesthesia, avoids the drawbacks of local anesthesia, enables precise tumor ablation, and improves lung function. Studies suggest that BTVA holds great promise for the treatment of both COPD and lung cancer, offering a new therapeutic option.
Based on the advantages of BTVA in the treatment of early-stage lung cancer and COPD, Researchers propose the concept of using BTVA to treat COPD combined with early-stage lung cancer. Researchers plan to conduct a multicenter clinical study focusing on patients with COPD combined with malignant GGNs. Bronchoscopic BTVA surgery or percutaneous MWA surgery will be performed, evaluating the effectiveness and safety of bronchoscopic BTVA and percutaneous MWA surgery in the treatment of COPD combined with early-stage lung cancer.
- Conditions
- Copd, Lung Cancer
- Being tested
- BTVA, MWA
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTVAProcedure or surgery
The eligible subjects will be stratified according to stratification factors (pure GGN/mixed GGN, lesion size ≤1cm/>1cm, FEV1 ≤50%/>50%) and randomized at a 1:1 ratio to two groups. Patients in the BTVA group will undergo BTVA treatment.
MWAProcedure or surgery
The eligible subjects will be stratified according to stratification factors (pure GGN/mixed GGN, lesion size ≤1cm/>1cm, FEV1 ≤50%/>50%) and randomized at a 1:1 ratio to two groups. Patients in the MWA group will undergo MWA treatment.
| Study group | Role | What they receive |
|---|---|---|
| bronchoscopic thermal vapor ablation | Experimental | Patients will undergo bronchoscopically guided thermal vapor ablation therapy Receives: Procedure: BTVA |
| percutaneous microwave ablation | Experimental | Patients will undergo CT-guided percutaneous microwave ablation therapy Receives: Procedure: MWA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete ablation rate at 12 months postoperatively
Measured: 12 months postoperatively
Secondary outcomes (10)
Technical implementation success rate
Measured: On the day of surgery
Complete ablation rate at 6 months postoperatively
Measured: 6 months postoperatively
Changes in pulmonary function indicators（FEV1） at 6 months, 12 months, and 24 months post-treatment compared to baseline
Measured: 6,12 and 24 months postoperatively
Changes in lung volume assessed by HRCT at 6 months, 12 months, and 24 months post-treatment compared to baseline
Measured: 6,12 and 24 months postoperatively
Improvement in exercise tolerance at 6 months, 12 months, and 24 months post-treatment compared to baseline: 6MWD
Measured: 6,12 and 24 months postoperatively
Improvement in symptom score（mMRC) at 6 months, 12 months, and 24 months post-treatment compared to baseline
Measured: 6,12 and 24 months postoperatively
Local control rates at 1 year, 2 years, and 3 years postoperatively
Measured: 1 year, 2 years, and 3 years postoperatively
Progression-free survival (PFS)
Measured: 1 year, 2 years, and 3 years postoperatively
Overall survival (OS)
Measured: 1 year, 2 years, and 3 years postoperatively
Safety：Evaluate the incidence of (serious) adverse events
Evaluate the incidence of (serious) adverse events related to the device or procedure during the study period.
Measured: On the day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929390
- Sponsor's protocol ID
- Xiaoju Zhang
- Status last verified
- Apr 2025
- First submitted
- 14 Jan 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Clinical Trial Comparing Bronchoscopic Thermal Vapor Ablation and Percutaneous Microwave Ablation in Patients With COPD and Early-Stage Lung Cancer: Efficacy and Safety Evaluation
- ClinicalTrials.gov ID
- NCT06929390
- Acronym / sponsor ID
- Xiaoju Zhang
- Conditions
- Copd, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 16 Apr 2025 (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.
Based on the advantages of BTVA in the treatment of early-stage lung cancer and COPD, researchers propose the concept of using BTVA to treat COPD combined with early-stage lung cancer. Researchers plan to conduct a multicenter clinical study focusing on patients with COPD combined with malignant GGNs. Bronchoscopic BTVA surgery or percutaneous MWA surgery will be performed, evaluating the effectiveness and safety of bronchoscopic BTVA and percutaneous MWA surgery in the treatment of COPD combined with early-stage lung cancer.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a common respiratory disease, affecting nearly 100 million people in China, with the highest mortality rate globally. It is strongly associated with lung cancer, as both share risk factors such as tobacco exposure and environmental pollution. Additionally, chronic inflammation and abnormal repair mechanisms in COPD further increase the risk of lung cancer. Early diagnosis and treatment of lung cancer are crucial, particularly in detecting pulmonary nodules (GGN). Although malignant GGNs progress slowly, early surgical resection remains the best curative option. However, COPD patients face high surgical risks and should carefully consider their treatment options.
Microwave ablation (MWA) has been widely used as a local treatment for early-stage lung cancer, showing similar efficacy to surgery. However, percutaneous procedures may lead to complications such as pneumothorax and bleeding. In contrast, bronchoscopic thermal vapor ablation (BTVA), performed under general anesthesia, avoids the drawbacks of local anesthesia, enables precise tumor ablation, and improves lung function. Studies suggest that BTVA holds great promise for the treatment of both COPD and lung cancer, offering a new therapeutic option.
Based on the advantages of BTVA in the treatment of early-stage lung cancer and COPD, Researchers propose the concept of using BTVA to treat COPD combined with early-stage lung cancer. Researchers plan to conduct a multicenter clinical study focusing on patients with COPD combined with malignant GGNs. Bronchoscopic BTVA surgery or percutaneous MWA surgery will be performed, evaluating the effectiveness and safety of bronchoscopic BTVA and percutaneous MWA surgery in the treatment of COPD combined with early-stage lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bronchoscopic thermal vapor ablation | Experimental | Procedure: BTVAPatients will undergo bronchoscopically guided thermal vapor ablation therapy |
| percutaneous microwave ablation | Experimental | Procedure: MWAPatients will undergo CT-guided percutaneous microwave ablation therapy |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients of any gender aged between 35 and 80 years with a diagnosis of chronic obstructive pulmonary disease (COPD);
- Chest CT showing ground-glass nodules (GGNs) with a solid/tumor ratio (CTR) ≤ 0.25;
- Nodule size < 2cm located in the upper lobes of both lungs;
- Pathologically diagnosed as primary peripheral lung cancer, with preoperative clinical staging indicating T1a, bN0M0;
- Investigator assessment that ablative techniques can be feasibly implemented via bronchoscopic or percutaneous approaches to reach the lesion;
Key exclusion criteria (19 listed)
- Bronchoscopy contraindications, such as:
- Pulmonary function reports indicating FEV1 ≤ 20% predicted value, or DLCO ≤ 20%;
- Respiratory tract infection or acute exacerbation of chronic obstructive pulmonary disease within the preceding 6 weeks before screening;
- Presence of large bullae in the lobe containing the target lung segment/subsegment (defined as bullae occupying more than 1/3 of the lobe) or paraseptal emphysema;
- High-density emphysematous changes simultaneously present in the upper and lower lobes of the contralateral lung, defined as HRCT showing low attenuation areas (<-950 HU) comprising more than 40% of the total lung volume;
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 |
|---|---|---|
| BTVAThe eligible subjects will be stratified according to stratification factors (pure GGN/mixed GGN, lesion size ≤1cm/>1cm, FEV1 ≤50%/>50%) and randomized at a 1:1 ratio to two groups. Patients in the BTVA group will undergo BTVA treatment. | Procedure or surgery | bronchoscopic thermal vapor ablation |
| MWAThe eligible subjects will be stratified according to stratification factors (pure GGN/mixed GGN, lesion size ≤1cm/>1cm, FEV1 ≤50%/>50%) and randomized at a 1:1 ratio to two groups. Patients in the MWA group will undergo MWA treatment. | Procedure or surgery | percutaneous microwave ablation |
Primary outcome
Complete ablation rate at 12 months postoperatively
Time frame: 12 months postoperatively
10 secondary outcomes
Technical implementation success rate
Time frame: On the day of surgery
Complete ablation rate at 6 months postoperatively
Time frame: 6 months postoperatively
Changes in pulmonary function indicators（FEV1） at 6 months, 12 months, and 24 months post-treatment compared to baseline
Time frame: 6,12 and 24 months postoperatively
Changes in lung volume assessed by HRCT at 6 months, 12 months, and 24 months post-treatment compared to baseline
Time frame: 6,12 and 24 months postoperatively
Improvement in exercise tolerance at 6 months, 12 months, and 24 months post-treatment compared to baseline: 6MWD
Time frame: 6,12 and 24 months postoperatively
Improvement in symptom score（mMRC) at 6 months, 12 months, and 24 months post-treatment compared to baseline
Time frame: 6,12 and 24 months postoperatively
Local control rates at 1 year, 2 years, and 3 years postoperatively
Time frame: 1 year, 2 years, and 3 years postoperatively
Progression-free survival (PFS)
Time frame: 1 year, 2 years, and 3 years postoperatively
Overall survival (OS)
Time frame: 1 year, 2 years, and 3 years postoperatively
Safety：Evaluate the incidence of (serious) adverse events
Time frame: On the day of surgery
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 18 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing BTVA and MWA in people with Copd and Lung Cancer, run by Henan Provincial People's Hospital.
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 8 inclusion and 19 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: opening soon, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Quncheng Zhang, Master (15038142486, zhangqc@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete ablation rate at 12 months postoperatively (time frame: 12 months postoperatively). 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 18 Apr 2025.