Lung CancerNCT04730453
ENB-guided Ablation Therapy Combined With VATS in the Treatment of MPLC
An observational study of Lung Cancer, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
The study is designed as a prospective trial whose purpose is to evaluate the effectiveness and safety of ENB-guided ablation therapy combined with VATS in the treatment of multiple primary lung cancers (MPLC). Read more about this study
- Who is it for?
- Ages 18 minutes and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- ENB-guided ablation therapy combined with VATS
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 24 Jul 2020to Dec 2025
- Phase
- Observational
- 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 18 minutes and older
- All sexes
- Child, Adult, Older adult
Study population: Patients who meet inclusion/exclusion will be enrolled in the study consecutively.
Who may be able to join
- Age ≥ 18 years old.
- The subject is diagnosed as multiple primary lung cancer via preoperative imaging/pathological examination.
- Thin-slice CT images show that the ablation Lesion A is accessible/adjacent to bronchi and the size is ≤ 3 cm.
- The subject with multiple primary lung cancers can be treated with ENB-guided ablation therapy combined with VATS according to multidisciplinary assessment.
Who cannot join
- The subject who cannot tolerate general anesthesia for their cardiopulmonary function, or there are other contraindications, such as uncorrectable coagulopathy.
- The situation in which the investigators think that the subject is not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Jiayuan Sun, MD, PhD, 86-021-22200000 ext. 1511, xkyyjysun@163.com
About this study
Official title: Electromagnetic Navigation Bronchoscopy Guided Ablation Therapy Combined With VATS in the Treatment of Multiple Primary Lung Cancers
The study is designed as a prospective trial whose purpose is to evaluate the effectiveness and safety of ENB-guided ablation therapy combined with VATS in the treatment of multiple primary lung cancers (MPLC).
Read the detailed description
Patients will be first screened, and only after meeting all the selection criteria, not meeting any exclusion criteria, and signing the informed consent, could they be enrolled in the group to receive ENB-guided ablation therapy combined with VATS. The primary endpoint is objective response rate (ORR). The secondary endpoints include progression-free survival (PFS), overall survival (OS) and safety.
- Conditions
- Lung Cancer
- Being tested
- ENB-guided ablation therapy combined with VATS
- Keywords
- Electromagnetic Navigation Bronchoscopy (ENB), Video-Assisted Thoracic Surgery (VATS), Multiple Primary Lung Cancers (MPLC), Ablation Therapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENB-guided ablation therapy combined with VATSProcedure or surgery
After receiving multidisciplinary assessments, Lesion A will receive ENB-guided ablation therapy and Lesion B will receive VATS at the same time.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of ablation efficacy, ORR (objective response rate)
ORR is defined as the proportion of patients with complete response (CR) and partial response (PR) after ablation therapy. Efficacy evaluation is based on Modifield Response Evaluation Criteria in Solid Tumors (mRECIST).
Measured: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 years.
Secondary outcomes (3)
Evaluation of ablation efficacy, PFS (progression-free survival)
PFS is defined as the time from the start of treatment to the first occurrence of disease progression or death for any cause.
Measured: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Evaluation of ablation efficacy, OS (overall survival)
OS is defined as the time from the start of treatment to the death of the patient.
Measured: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
Observation of complications of ablation
Complications refer to the combination of serious adverse events related to the operation during or after the operation, mainly including pneumothorax and bleeding.
Measured: From date of treatment to the one month after ablation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start24 Jul 2020
- Primary completionJan 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayuan Sun, Shanghai Chest Hospital
- Investigators
- Jiayuan Sun, MD, PhD, Study director, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730453
- Sponsor's protocol ID
- SHCHE202101
- Status last verified
- Jan 2021
- First submitted
- 24 Jan 2021
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Howington JA, Blum MG, Chang AC, Balekian AA, Murthy SC. Treatment of stage I and II non-small cell lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e278S-e313S. doi: 10.1378/chest.12-2359.
PubMed 23649443Ambrogi MC, Fanucchi O, Dini P, Melfi F, Davini F, Lucchi M, Massimetti G, Mussi A. Wedge resection and radiofrequency ablation for stage I nonsmall cell lung cancer. Eur Respir J. 2015 Apr;45(4):1089-97. doi: 10.1183/09031936.00188014. Epub 2015 Feb 19.
PubMed 25700387Ye X, Fan W, Wang H, Wang J, Wang Z, Gu S, Feng W, Zhuang Y, Liu B, Li X, Li Y, Li C, Xiao Y, Yang P, Yang X, Yang W, Chen J, Zhang R, Lin Z, Meng Z, Hu K, Liu C, Peng Z, Han Y, Jin Y, Lei G, Zhai B, Huang G. Expert consensus workshop report: Guidelines for thermal ablation of primary and metastatic lung tumors (2018 edition). J Cancer Res Ther. 2018;14(4):730-744. doi: 10.4103/jcrt.JCRT_221_18.
PubMed 29970646Harris K, Puchalski J, Sterman D. Recent Advances in Bronchoscopic Treatment of Peripheral Lung Cancers. Chest. 2017 Mar;151(3):674-685. doi: 10.1016/j.chest.2016.05.025. Epub 2016 Jun 10.
PubMed 27292045Tsushima K, Koizumi T, Tanabe T, Nakagawa R, Yoshikawa S, Yasuo M, Kubo K. Bronchoscopy-guided radiofrequency ablation as a potential novel therapeutic tool. Eur Respir J. 2007 Jun;29(6):1193-200. doi: 10.1183/09031936.00111306. Epub 2007 Mar 14.
PubMed 17360727Tanabe T, Koizumi T, Tsushima K, Ito M, Kanda S, Kobayashi T, Yasuo M, Yamazaki Y, Kubo K, Honda T, Kondo R, Yoshida K. Comparative study of three different catheters for CT imaging-bronchoscopy-guided radiofrequency ablation as a potential and novel interventional therapy for lung cancer. Chest. 2010 Apr;137(4):890-7. doi: 10.1378/chest.09-1065. Epub 2009 Oct 26.
PubMed 19858232Xie F, Zheng X, Xiao B, Han B, Herth FJF, Sun J. Navigation Bronchoscopy-Guided Radiofrequency Ablation for Nonsurgical Peripheral Pulmonary Tumors. Respiration. 2017;94(3):293-298. doi: 10.1159/000477764. Epub 2017 Jul 6.
PubMed 28683443
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromagnetic Navigation Bronchoscopy Guided Ablation Therapy Combined With VATS in the Treatment of Multiple Primary Lung Cancers
- ClinicalTrials.gov ID
- NCT04730453
- Acronym / sponsor ID
- SHCHE202101
- Conditions
- Lung Cancer
- Keywords
- Electromagnetic Navigation Bronchoscopy (ENB), Video-Assisted Thoracic Surgery (VATS), Multiple Primary Lung Cancers (MPLC), Ablation Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Jan 2021 (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 study is designed as a prospective trial whose purpose is to evaluate the effectiveness and safety of ENB-guided ablation therapy combined with VATS in the treatment of multiple primary lung cancers (MPLC).
Detailed description
Patients will be first screened, and only after meeting all the selection criteria, not meeting any exclusion criteria, and signing the informed consent, could they be enrolled in the group to receive ENB-guided ablation therapy combined with VATS. The primary endpoint is objective response rate (ORR). The secondary endpoints include progression-free survival (PFS), overall survival (OS) and safety.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 minutes and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who meet inclusion/exclusion will be enrolled in the study consecutively.
Key inclusion criteria (4 listed)
- Age ≥ 18 years old.
- The subject is diagnosed as multiple primary lung cancer via preoperative imaging/pathological examination.
- Thin-slice CT images show that the ablation Lesion A is accessible/adjacent to bronchi and the size is ≤ 3 cm.
- The subject with multiple primary lung cancers can be treated with ENB-guided ablation therapy combined with VATS according to multidisciplinary assessment.
Key exclusion criteria (2 listed)
- The subject who cannot tolerate general anesthesia for their cardiopulmonary function, or there are other contraindications, such as uncorrectable coagulopathy.
- The situation in which the investigators think that the subject is not suitable to participate in this study.
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 |
|---|---|---|
| ENB-guided ablation therapy combined with VATSAfter receiving multidisciplinary assessments, Lesion A will receive ENB-guided ablation therapy and Lesion B will receive VATS at the same time. | Procedure or surgery | – |
Primary outcome
Evaluation of ablation efficacy, ORR (objective response rate)
Time frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 years.
ORR is defined as the proportion of patients with complete response (CR) and partial response (PR) after ablation therapy. Efficacy evaluation is based on Modifield Response Evaluation Criteria in Solid Tumors (mRECIST).
3 secondary outcomes
Evaluation of ablation efficacy, PFS (progression-free survival)
Time frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Evaluation of ablation efficacy, OS (overall survival)
Time frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
Observation of complications of ablation
Time frame: From date of treatment to the one month after ablation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Background: PubMed 23649443Howington JA, Blum MG, Chang AC, Balekian AA, Murthy SC. Treatment of stage I and II non-small cell lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e278S-e313S. doi: 10.1378/chest.12-2359.
- Background: PubMed 25700387Ambrogi MC, Fanucchi O, Dini P, Melfi F, Davini F, Lucchi M, Massimetti G, Mussi A. Wedge resection and radiofrequency ablation for stage I nonsmall cell lung cancer. Eur Respir J. 2015 Apr;45(4):1089-97. doi: 10.1183/09031936.00188014. Epub 2015 Feb 19.
- Background: PubMed 29970646Ye X, Fan W, Wang H, Wang J, Wang Z, Gu S, Feng W, Zhuang Y, Liu B, Li X, Li Y, Li C, Xiao Y, Yang P, Yang X, Yang W, Chen J, Zhang R, Lin Z, Meng Z, Hu K, Liu C, Peng Z, Han Y, Jin Y, Lei G, Zhai B, Huang G. Expert consensus workshop report: Guidelines for thermal ablation of primary and metastatic lung tumors (2018 edition). J Cancer Res Ther. 2018;14(4):730-744. doi: 10.4103/jcrt.JCRT_221_18.
- Background: PubMed 27292045Harris K, Puchalski J, Sterman D. Recent Advances in Bronchoscopic Treatment of Peripheral Lung Cancers. Chest. 2017 Mar;151(3):674-685. doi: 10.1016/j.chest.2016.05.025. Epub 2016 Jun 10.
- Background: PubMed 17360727Tsushima K, Koizumi T, Tanabe T, Nakagawa R, Yoshikawa S, Yasuo M, Kubo K. Bronchoscopy-guided radiofrequency ablation as a potential novel therapeutic tool. Eur Respir J. 2007 Jun;29(6):1193-200. doi: 10.1183/09031936.00111306. Epub 2007 Mar 14.
- Background: PubMed 19858232Tanabe T, Koizumi T, Tsushima K, Ito M, Kanda S, Kobayashi T, Yasuo M, Yamazaki Y, Kubo K, Honda T, Kondo R, Yoshida K. Comparative study of three different catheters for CT imaging-bronchoscopy-guided radiofrequency ablation as a potential and novel interventional therapy for lung cancer. Chest. 2010 Apr;137(4):890-7. doi: 10.1378/chest.09-1065. Epub 2009 Oct 26.
- Background: PubMed 28683443Xie F, Zheng X, Xiao B, Han B, Herth FJF, Sun J. Navigation Bronchoscopy-Guided Radiofrequency Ablation for Nonsurgical Peripheral Pulmonary Tumors. Respiration. 2017;94(3):293-298. doi: 10.1159/000477764. Epub 2017 Jul 6.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Jiayuan Sun, MD, 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?
An observational study of Lung Cancer, 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 2 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: status not confirmed, as of the sponsor's last update on 29 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiayuan Sun, MD, PhD (+86-021-22200000 ext. 1511, xkyyjysun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of ablation efficacy, ORR (objective response rate) (time frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04730453, which also lists 7 linked publications.
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 29 Jan 2021.