Esophageal Carcinoma in Situ AJCC V7NCT05208775
A Comparative Study of Endoscopic Submucosal Dissection and Photodynamic Therapy for Early Esophageal Cancer
A study testing PDT and ESD in people with Esophageal Carcinoma in Situ AJCC V7, run by The First Affiliated Hospital of Henan University of Science and Technology.
Trial summary
The purpose of this study was to compare the efficacy and safety of Photodynamic therapy (PDT) and Endoscopic submucosal (ESD) dissection in the treatment of early esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Carcinoma in Situ AJCC V7
- What is being tested?
- PDT and ESD
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 30 Dec 2024
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High-grade intraepithelial neoplasia of the esophagus
- 18-80 years old
- The tumor was confined to the lamina propria of the mucosa
- The tumor invaded the submucosa and was limited to 200 microns
Who cannot join
- The tumor invaded the entire circumference of the esophagus
- The tumor invaded the muscularis or submucosa more than 200 microns
- The patient has difficulty tolerating anesthesia due to other diseases
- Pregnant or breastfeeding women
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase III, Randomized, Controlled Study of Endoscopic Submucosal Dissection Versus Photodynamic Therapy for Early Esophageal Cancer
The purpose of this study was to compare the efficacy and safety of Photodynamic therapy (PDT) and Endoscopic submucosal (ESD) dissection in the treatment of early esophageal cancer.
Read the detailed description
Background: Photodynamic therapy (PDT) is recommended by the NCCN guidelines as an effective method for the treatment of early esophageal cancer. However, there is no clinical trial data so far on whether its efficacy can be compared with that of standard Endoscopic submucosal (ESD). Our team will conduct a detailed study on it.
Aim: to compare the efficacy and safety of Photodynamic therapy (PDT) and Endoscopic submucosal (ESD) dissection in the treatment of early esophageal cancer.
Methods: This study intends to recruit 46 patients with early esophageal cancer and randomly divide them into two groups: one group to receive ESD and the other group to receive PDT.The efficacy and safety were observed after 2 years of follow-up.
Primary endpoints: The recurrence rates at 3 months, 6 months, and 2 years were compared.
- Conditions
- Esophageal Carcinoma in Situ AJCC V7
- Being tested
- PDT, ESD
- Keywords
- Early esophageal carcinoma, Photodynamics Therapy, Endoscopic submucosal dissection
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDTProcedure or surgery
Also called Photodynamics Therapy
Drug: (Hematoporphyrin sodium injection) Hematoporphyrin sodium injection (xibofen):2mg/kg I.V.
Laser irradiation:
48 hours after the patient input the photosensitizer, the laser irradiation time is 900 seconds, and the output power is 200 watts.
ESDProcedure or surgery
Also called Endoscopic submucosal dissection
The patients received standard endoscopic submucosal dissection after enrollment.
| Study group | Role | What they receive |
|---|---|---|
| PDT group | Experimental | After enrollment, patients were injected with photosensitizer at a dose of 2mg/kg, and received photodynamic irradiation 48 hours later. Receives: Procedure: PDT |
| ESD group | Active comparator | Patients received standard ESD treatment after enrollment Receives: Procedure: ESD |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year disease-free survival rate
The percent of 2 year disease-free survival after random allocation, percent
Measured: 2 year
Secondary outcomes (1)
Esophageal stenosis rate at 3 months
Stenosis rate of esophagus after 3 months
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 posted26 Jan 2022
- Study start1 Mar 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Esophageal Carcinoma in Situ AJCC V7Studies 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
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Henan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shegan Gao, MD, PhD, Study chair, The First Affiliated Hospital and College of Henan University of Science and TechnologyTanyou Shan, MD, PhD, Study director, The First Affiliated Hospital and College of Henan University of Science and TechnologyLijuan Wu, MD, PhD, Study director, The First Affiliated Hospital and College of Henan University of Science and TechnologyCaihong Dong, MD，PhD, Principal investigator, The First Affiliated Hospital and College of Henan University of Science and TechnologyJiachun Sun, MD, PhD, Principal investigator, The First Affiliated Hospital and College of Henan University of Science and TechnologyWanying Li, MD, Principal investigator, The First Affiliated Hospital and College of Henan University of Science and TechnologyXiaozhi Yuan, MD, PhD, Principal investigator, The First Affiliated Hospital and College of Henan University of Science and TechnologyMengxi Zhang, MD, Principal investigator, The First Affiliated Hospital and College of Henan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208775
- Sponsor's protocol ID
- ECPDT-002
- Status last verified
- Dec 2021
- First submitted
- 10 Jan 2022
- Last updated
- 26 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yano T, Minamide T, Takashima K, Nakajo K, Kadota T, Yoda Y. Clinical Practice of Photodynamic Therapy Using Talaporfin Sodium for Esophageal Cancer. J Clin Med. 2021 Jun 24;10(13):2785. doi: 10.3390/jcm10132785.
PubMed 34202917National Health Commission Of The People's Republic Of China. Chinese guidelines for diagnosis and treatment of esophageal carcinoma 2018 (English version). Chin J Cancer Res. 2019 Apr;31(2):223-258. doi: 10.21147/j.issn.1000-9604.2019.02.01. No abstract available.
PubMed 31156297Zeng R, Liu C, Li L, Cai X, Chen R, Li Z. Clinical Efficacy of HiPorfin Photodynamic Therapy for Advanced Obstructive Esophageal Cancer. Technol Cancer Res Treat. 2020 Jan-Dec;19:1533033820930335. doi: 10.1177/1533033820930335.
PubMed 32578508Yoon HY, Cheon YK, Choi HJ, Shim CS. Role of photodynamic therapy in the palliation of obstructing esophageal cancer. Korean J Intern Med. 2012 Sep;27(3):278-84. doi: 10.3904/kjim.2012.27.3.278. Epub 2012 Sep 1.
PubMed 23019392Itabashi M, Nasierowska-Guttmejer A, Shimoda T, Majewski P, Rezner W, Sikora K, Srutek E, Steplewska K, Swatek J, Szumilo J, Wierzchniewska-Lawska A, Wronecki L, Zembala-Nozynska E, Arai T, Fujita M, Kawachi H, Unakami M, Kamoshida T. The importance of the concept and histological criteria of "intraepithelial squamous cell carcinoma" of the esophagus: in comparison between Western and Japanese criteria. Esophagus. 2017;14(4):333-342. doi: 10.1007/s10388-017-0583-7. Epub 2017 Jun 14.
PubMed 28983230Zheng JY, Chen YH, Chen YY, Zheng XL, Zhong SS, Deng WY, Zheng JH, Guo XB, Gao LY, Liang W. Presence of pink-color sign within 1 min after iodine staining has high diagnostic accordance rate for esophageal high-grade intraepithelial neoplasia/invasive cancer. Saudi J Gastroenterol. 2019 Mar-Apr;25(2):113-118. doi: 10.4103/sjg.SJG_274_18.
PubMed 30588952Omae M, Hagstrom H, Ndegwa N, Vieth M, Wang N, Vujasinovic M, Baldaque-Silva F. Wide-field endoscopic submucosal dissection for the treatment of Barrett's esophagus neoplasia. Endosc Int Open. 2021 May;9(5):E727-E734. doi: 10.1055/a-1386-3668. Epub 2021 Apr 22.
PubMed 33937514Wu W, Wu YL, Zhu YB, Wei Q, Guo Y, Zhu ZG, Yuan YZ. Endoscopic features predictive of gastric cancer in superficial lesions with biopsy-proven high grade intraepithelial neoplasia. World J Gastroenterol. 2009 Jan 28;15(4):489-95. doi: 10.3748/wjg.15.489.
PubMed 19152456Ke Y, van Munster SN, Xue L, He S, Zhang Y, Dou L, Liu Y, Liu X, Liu Y, Li W, Lv N, Dawsey SM, Weusten BLAM, Bergman JJGHM, Wang G. Prospective study of endoscopic focal cryoballoon ablation for esophageal squamous cell neoplasia in China. Gastrointest Endosc. 2019 Aug;90(2):204-212. doi: 10.1016/j.gie.2019.03.017. Epub 2019 Mar 25.
PubMed 30922862
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Controlled Study of Endoscopic Submucosal Dissection Versus Photodynamic Therapy for Early Esophageal Cancer
- ClinicalTrials.gov ID
- NCT05208775
- Acronym / sponsor ID
- ECPDT-002
- Conditions
- Esophageal Carcinoma in Situ AJCC V7
- Keywords
- Early esophageal carcinoma, Photodynamics Therapy, Endoscopic submucosal dissection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Henan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 26 Jan 2022 (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 purpose of this study was to compare the efficacy and safety of Photodynamic therapy (PDT) and Endoscopic submucosal (ESD) dissection in the treatment of early esophageal cancer.
Detailed description
Background: Photodynamic therapy (PDT) is recommended by the NCCN guidelines as an effective method for the treatment of early esophageal cancer. However, there is no clinical trial data so far on whether its efficacy can be compared with that of standard Endoscopic submucosal (ESD). Our team will conduct a detailed study on it.
Aim: to compare the efficacy and safety of Photodynamic therapy (PDT) and Endoscopic submucosal (ESD) dissection in the treatment of early esophageal cancer.
Methods: This study intends to recruit 46 patients with early esophageal cancer and randomly divide them into two groups: one group to receive ESD and the other group to receive PDT.The efficacy and safety were observed after 2 years of follow-up.
Primary endpoints: The recurrence rates at 3 months, 6 months, and 2 years were compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDT group | Experimental | Procedure: PDTAfter enrollment, patients were injected with photosensitizer at a dose of 2mg/kg, and received photodynamic irradiation 48 hours later. |
| ESD group | Active comparator | Procedure: ESDPatients received standard ESD treatment after enrollment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- High-grade intraepithelial neoplasia of the esophagus
- 18-80 years old
- The tumor was confined to the lamina propria of the mucosa
- The tumor invaded the submucosa and was limited to 200 microns
Key exclusion criteria (4 listed)
- The tumor invaded the entire circumference of the esophagus
- The tumor invaded the muscularis or submucosa more than 200 microns
- The patient has difficulty tolerating anesthesia due to other diseases
- Pregnant or breastfeeding women
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 |
|---|---|---|
| PDTAlso: Photodynamics TherapyDrug: (Hematoporphyrin sodium injection) Hematoporphyrin sodium injection (xibofen):2mg/kg I.V. Laser irradiation: 48 hours after the patient input the photosensitizer, the laser irradiation time is 900 seconds, and the output power is 200 watts. | Procedure or surgery | PDT group |
| ESDAlso: Endoscopic submucosal dissectionThe patients received standard endoscopic submucosal dissection after enrollment. | Procedure or surgery | ESD group |
Primary outcome
2-year disease-free survival rate
Time frame: 2 year
The percent of 2 year disease-free survival after random allocation, percent
1 secondary outcome
Esophageal stenosis rate at 3 months
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Background: PubMed 34202917Yano T, Minamide T, Takashima K, Nakajo K, Kadota T, Yoda Y. Clinical Practice of Photodynamic Therapy Using Talaporfin Sodium for Esophageal Cancer. J Clin Med. 2021 Jun 24;10(13):2785. doi: 10.3390/jcm10132785.
- Background: PubMed 31156297National Health Commission Of The People's Republic Of China. Chinese guidelines for diagnosis and treatment of esophageal carcinoma 2018 (English version). Chin J Cancer Res. 2019 Apr;31(2):223-258. doi: 10.21147/j.issn.1000-9604.2019.02.01. No abstract available.
- Background: PubMed 32578508Zeng R, Liu C, Li L, Cai X, Chen R, Li Z. Clinical Efficacy of HiPorfin Photodynamic Therapy for Advanced Obstructive Esophageal Cancer. Technol Cancer Res Treat. 2020 Jan-Dec;19:1533033820930335. doi: 10.1177/1533033820930335.
- Background: PubMed 23019392Yoon HY, Cheon YK, Choi HJ, Shim CS. Role of photodynamic therapy in the palliation of obstructing esophageal cancer. Korean J Intern Med. 2012 Sep;27(3):278-84. doi: 10.3904/kjim.2012.27.3.278. Epub 2012 Sep 1.
- Background: PubMed 28983230Itabashi M, Nasierowska-Guttmejer A, Shimoda T, Majewski P, Rezner W, Sikora K, Srutek E, Steplewska K, Swatek J, Szumilo J, Wierzchniewska-Lawska A, Wronecki L, Zembala-Nozynska E, Arai T, Fujita M, Kawachi H, Unakami M, Kamoshida T. The importance of the concept and histological criteria of "intraepithelial squamous cell carcinoma" of the esophagus: in comparison between Western and Japanese criteria. Esophagus. 2017;14(4):333-342. doi: 10.1007/s10388-017-0583-7. Epub 2017 Jun 14.
- Background: PubMed 30588952Zheng JY, Chen YH, Chen YY, Zheng XL, Zhong SS, Deng WY, Zheng JH, Guo XB, Gao LY, Liang W. Presence of pink-color sign within 1 min after iodine staining has high diagnostic accordance rate for esophageal high-grade intraepithelial neoplasia/invasive cancer. Saudi J Gastroenterol. 2019 Mar-Apr;25(2):113-118. doi: 10.4103/sjg.SJG_274_18.
- Background: PubMed 33937514Omae M, Hagstrom H, Ndegwa N, Vieth M, Wang N, Vujasinovic M, Baldaque-Silva F. Wide-field endoscopic submucosal dissection for the treatment of Barrett's esophagus neoplasia. Endosc Int Open. 2021 May;9(5):E727-E734. doi: 10.1055/a-1386-3668. Epub 2021 Apr 22.
- Background: PubMed 19152456Wu W, Wu YL, Zhu YB, Wei Q, Guo Y, Zhu ZG, Yuan YZ. Endoscopic features predictive of gastric cancer in superficial lesions with biopsy-proven high grade intraepithelial neoplasia. World J Gastroenterol. 2009 Jan 28;15(4):489-95. doi: 10.3748/wjg.15.489.
- Background: PubMed 30922862Ke Y, van Munster SN, Xue L, He S, Zhang Y, Dou L, Liu Y, Liu X, Liu Y, Li W, Lv N, Dawsey SM, Weusten BLAM, Bergman JJGHM, Wang G. Prospective study of endoscopic focal cryoballoon ablation for esophageal squamous cell neoplasia in China. Gastrointest Endosc. 2019 Aug;90(2):204-212. doi: 10.1016/j.gie.2019.03.017. Epub 2019 Mar 25.
- Individual participant dataSharing planned: No
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.
Shegan Gao, MD, PhD study chair
The First Affiliated Hospital and College of Henan University of Science and Technology
Tanyou Shan, MD, PhD study director
The First Affiliated Hospital and College of Henan University of Science and Technology
Lijuan Wu, MD, PhD study director
The First Affiliated Hospital and College of Henan University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A study testing PDT and ESD in people with Esophageal Carcinoma in Situ AJCC V7, run by The First Affiliated Hospital of Henan University of Science and Technology.
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 4 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 26 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shegan Gao, MD, PhD (18638859977, gsg112258@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year disease-free survival rate (time frame: 2 year). 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 NCT05208775, which also lists 9 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 26 Jan 2022.