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A Comparative Study of Endoscopic Submucosal Dissection and Photodynamic Therapy for Early Esophageal Cancer

Primary Purpose

Esophageal Carcinoma in Situ AJCC V7

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PDT
ESD
Sponsored by
The First Affiliated Hospital of Henan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Carcinoma in Situ AJCC V7 focused on measuring Early esophageal carcinoma, Photodynamics Therapy, Endoscopic submucosal dissection

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    PDT group

    ESD group

    Arm Description

    After enrollment, patients were injected with photosensitizer at a dose of 2mg/kg, and received photodynamic irradiation 48 hours later.

    Patients received standard ESD treatment after enrollment

    Outcomes

    Primary Outcome Measures

    2-year disease-free survival rate
    The percent of 2 year disease-free survival after random allocation, percent

    Secondary Outcome Measures

    Esophageal stenosis rate at 3 months
    Stenosis rate of esophagus after 3 months

    Full Information

    First Posted
    January 10, 2022
    Last Updated
    January 17, 2022
    Sponsor
    The First Affiliated Hospital of Henan University of Science and Technology
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05208775
    Brief Title
    A Comparative Study of Endoscopic Submucosal Dissection and Photodynamic Therapy for Early Esophageal Cancer
    Official Title
    A Phase III, Randomized, Controlled Study of Endoscopic Submucosal Dissection Versus Photodynamic Therapy for Early Esophageal Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    December 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First Affiliated Hospital of Henan University of Science and Technology

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophageal Carcinoma in Situ AJCC V7
    Keywords
    Early esophageal carcinoma, Photodynamics Therapy, Endoscopic submucosal dissection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    46 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PDT group
    Arm Type
    Experimental
    Arm Description
    After enrollment, patients were injected with photosensitizer at a dose of 2mg/kg, and received photodynamic irradiation 48 hours later.
    Arm Title
    ESD group
    Arm Type
    Active Comparator
    Arm Description
    Patients received standard ESD treatment after enrollment
    Intervention Type
    Procedure
    Intervention Name(s)
    PDT
    Other Intervention Name(s)
    Photodynamics Therapy
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    ESD
    Other Intervention Name(s)
    Endoscopic submucosal dissection
    Intervention Description
    The patients received standard endoscopic submucosal dissection after enrollment.
    Primary Outcome Measure Information:
    Title
    2-year disease-free survival rate
    Description
    The percent of 2 year disease-free survival after random allocation, percent
    Time Frame
    2 year
    Secondary Outcome Measure Information:
    Title
    Esophageal stenosis rate at 3 months
    Description
    Stenosis rate of esophagus after 3 months
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shegan Gao, MD, PhD
    Phone
    18638859977
    Email
    gsg112258@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tanyou Shan, MD, PhD
    Phone
    18537976669
    Email
    shantanyoudoctor@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shegan Gao, MD, PhD
    Organizational Affiliation
    The First Affiliated Hospital and College of Henan University of Science and Technology
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Tanyou Shan, MD, PhD
    Organizational Affiliation
    The First Affiliated Hospital and College of Henan University of Science and Technology
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Lijuan Wu, MD, PhD
    Organizational Affiliation
    The First Affiliated Hospital and College of Henan University of Science and Technology
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Caihong Dong, MD，PhD
    Organizational Affiliation
    The First Affiliated Hospital and College of Henan University of Science and Technology
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jiachun Sun, MD, PhD
    Organizational Affiliation
    The First Affiliated Hospital and College of Henan University of Science and Technology
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Wanying Li, MD
    Organizational Affiliation
    The First Affiliated Hospital and College of Henan University of Science and Technology
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Xiaozhi Yuan, MD, PhD
    Organizational Affiliation
    The First Affiliated Hospital and College of Henan University of Science and Technology
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Mengxi Zhang, MD
    Organizational Affiliation
    The First Affiliated Hospital and College of Henan University of Science and Technology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34202917
    Citation
    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.
    Results Reference
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    PubMed Identifier
    31156297
    Citation
    National 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.
    Results Reference
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    PubMed Identifier
    32578508
    Citation
    Zeng 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.
    Results Reference
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    PubMed Identifier
    23019392
    Citation
    Yoon 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.
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    Itabashi 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.
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    A Comparative Study of Endoscopic Submucosal Dissection and Photodynamic Therapy for Early Esophageal Cancer

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