Lung NeoplasmsNCT03537378
Hybrid APC Therapy in Early Central Lung Neoplasms
A study testing Hybrid APC in people with Lung Neoplasms, run by Jiayuan Sun at 1 site in China.
Trial summary
1.1 Aims：This cohort study aims to investigate the clinical value of Hybrid APC for treatment of early central lung neoplasms. 1.2 methods：A total of 30 patients with early central lung neoplasms will be included in this open, multicenter, prospective study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Hybrid APC
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2018to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Bronchoscopy and fluorescence bronchoscopy found endoluminal growth lesions of upper segmental bronchus. AFB indicates malignant possibility.
- Size ≤ 20 mm
- Flat, nodule or polypoid type
- Negative imaging: HRCT indicates no tumor in lung and lymph node enlargement; or PET-CT finds no lesions in lung or suspicious lymph node tumors involve.
- Clinical stage: Tis or T1N0M0
- High-grade intraepithelial neoplasia (including severe atypical dysplasia and carcinoma in situ) mucoepidermoid carcinomaand ,squamous cancer and etc. confirmed by biopsy histopathology
Show all 9Show fewer
- High-frequency EBUS indicates the depth of lesions is cartilage endomembrane or internal part of adventitia of tracheal membranous part
- Patients are not suitable for surgery or refuse surgery
- Inform consent is available
Who cannot join
- Patients with severe cardiopulmonary dysfunction or other contraindication can not tolerate endoscopic examination and treatment
- Severe bleeding tendency
- Poor compliance
- Unstable vital signs
- Investigators consider subjects should not be included because of specific situations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Center Clinical Study of the Hybrid APC Therapy in Early Central Lung Neoplasms
1.1 Aims：This cohort study aims to investigate the clinical value of Hybrid APC for treatment of early central lung neoplasms.
1.2 methods：A total of 30 patients with early central lung neoplasms will be included in this open, multicenter, prospective study. Primary observation endpoint is recorded at 3 months follow-up, and after 3 months patients could be continued to follow up. The data are expressed in terms of mean and percentage. The categorical variables are analyzed by chi-square test, and the four table data is analyzed using the exact probability method. The continuous variable analysis is used by t test. Statistical analysis is performed with SPSS 20.0 software. P < 0.05 is considered statistically significant.
Read the detailed description
This is a prospective, multicenter, and cohort study. Study subjects: patients with early central lung neoplasms meet inclusion/exclusion criteria and could receive interventional therapy.
There are 3 study site in this study and a total of 30 patients with early central lung cancer will be included.
HybridAPC is integrated with traditional APC and water-jet technique, which has been successfully applied for endoscopic treatment of mucosal lesions in GI, such as Barrett esophageal and lesions in colon. Submucosal injection of water jet can elevate superficial lesion, and then APC can be more effective in ablation of superficial tumor with a protection for muscular layer. The application of HybridAPC in respiratory intervention could theoretically protect cartilage, adventitia, reduce damage and formation of scare, and increase ablation energy to reach radical treatment.
- Conditions
- Lung Neoplasms
- Being tested
- Hybrid APC
- Keywords
- Hybrid APC,Early Central Lung Neoplasms,
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid APCProcedure or surgery
- HybridAPC is integrated with traditional APC and water-jet technique, which has been successfully applied for endoscopic treatment of mucosal lesions in GI, such as Barrett esophageal and lesions in colon. Submucosal injection of water jet can elevate superficial lesion, and then APC can be more effective in ablation of superficial tumor with a protection for muscular layer. The application of HybridAPC in respiratory intervention could theoretically protect cartilage, adventitia, reduce damage and formation of scare, and increase ablation energy to reach radical treatment. • High-frequency EBUS, could display the boundary between cartilage endomembrane and cartilage, in order to determine the depth of tumor.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid APC Therapy Group | Experimental | 1) Patients are diagnosed as early central lung neoplasms (severe dysplasia, carcinoma in situ, microinvasive carcinoma，mucoepidermoid carcinoma.etc.) by inquiry of the first doctor, CT test, endoscopy and histopathology. Patients who meet inclusion/exclusion criteria are not suitable for or refuse surgery. Receives: Procedure: Hybrid APC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful remission rate:
successful remission is defined as absence of intraepithelial neoplasia in biopsies of original locations at 3 months after HybridAPC upon follow up
Measured: 3 months
Secondary outcomes (1)
Complications
possible complications include perforation, bleeding, fever, stenosis, cough and etc.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start26 Dec 2018
- Primary completion22 Feb 2022
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiayuan Sun
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China, The First Affiliated Hospital of Guangzhou Medical University
- Responsible party
- Sponsor-investigator, Jiayuan Sun, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537378
- Sponsor's protocol ID
- SHCHE201801
- Status last verified
- Jul 2025
- First submitted
- 15 May 2018
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Clinical Study of the Hybrid APC Therapy in Early Central Lung Neoplasms
- ClinicalTrials.gov ID
- NCT03537378
- Acronym / sponsor ID
- SHCHE201801
- Conditions
- Lung Neoplasms
- Keywords
- Hybrid APC,Early Central Lung Neoplasms,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Jiayuan SunUniversity, hospital or other
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China, The First Affiliated Hospital of Guangzhou Medical University
- Study start
- 26 Dec 2018 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 25 May 2018 (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.
1.1 Aims：This cohort study aims to investigate the clinical value of Hybrid APC for treatment of early central lung neoplasms.
1.2 methods：A total of 30 patients with early central lung neoplasms will be included in this open, multicenter, prospective study. Primary observation endpoint is recorded at 3 months follow-up, and after 3 months patients could be continued to follow up. The data are expressed in terms of mean and percentage. The categorical variables are analyzed by chi-square test, and the four table data is analyzed using the exact probability method. The continuous variable analysis is used by t test. Statistical analysis is performed with SPSS 20.0 software. P < 0.05 is considered statistically significant.
Detailed description
This is a prospective, multicenter, and cohort study. Study subjects: patients with early central lung neoplasms meet inclusion/exclusion criteria and could receive interventional therapy.
There are 3 study site in this study and a total of 30 patients with early central lung cancer will be included.
HybridAPC is integrated with traditional APC and water-jet technique, which has been successfully applied for endoscopic treatment of mucosal lesions in GI, such as Barrett esophageal and lesions in colon. Submucosal injection of water jet can elevate superficial lesion, and then APC can be more effective in ablation of superficial tumor with a protection for muscular layer. The application of HybridAPC in respiratory intervention could theoretically protect cartilage, adventitia, reduce damage and formation of scare, and increase ablation energy to reach radical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hybrid APC Therapy Group | Experimental | Procedure: Hybrid APC1) Patients are diagnosed as early central lung neoplasms (severe dysplasia, carcinoma in situ, microinvasive carcinoma，mucoepidermoid carcinoma.etc.) by inquiry of the first doctor, CT test, endoscopy and histopathology. Patients who meet inclusion/exclusion criteria are not suitable for or refuse surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Bronchoscopy and fluorescence bronchoscopy found endoluminal growth lesions of upper segmental bronchus. AFB indicates malignant possibility.
- Size ≤ 20 mm
- Flat, nodule or polypoid type
- Negative imaging: HRCT indicates no tumor in lung and lymph node enlargement; or PET-CT finds no lesions in lung or suspicious lymph node tumors involve.
- Clinical stage: Tis or T1N0M0
Key exclusion criteria (5 listed)
- Patients with severe cardiopulmonary dysfunction or other contraindication can not tolerate endoscopic examination and treatment
- Severe bleeding tendency
- Poor compliance
- Unstable vital signs
- Investigators consider subjects should not be included because of specific situations
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 |
|---|---|---|
| Hybrid APC• HybridAPC is integrated with traditional APC and water-jet technique, which has been successfully applied for endoscopic treatment of mucosal lesions in GI, such as Barrett esophageal and lesions in colon. Submucosal injection of water jet can elevate superficial lesion, and then APC can be more effective in ablation of superficial tumor with a protection for muscular layer. The application of HybridAPC in respiratory intervention could theoretically protect cartilage, adventitia, reduce damage and formation of scare, and increase ablation energy to reach radical treatment. • High-frequency EBUS, could display the boundary between cartilage endomembrane and cartilage, in order to determine the depth of tumor. | Procedure or surgery | Hybrid APC Therapy Group |
Primary outcome
Successful remission rate:
Time frame: 3 months
successful remission is defined as absence of intraepithelial neoplasia in biopsies of original locations at 3 months after HybridAPC upon follow up
1 secondary outcome
Complications
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid APC in people with Lung Neoplasms, run by Jiayuan Sun 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 9 inclusion and 5 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: finished, as of the sponsor's last update on 10 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful remission rate: (time frame: 3 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 10 Jul 2025.