NCT05174117

Brief Summary

The purpose of this experiment is to study the alleviating effects and side effects of different laser irradiation doses on esophageal stricture of esophageal cancer in order to find the appropriate dose of light.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 30, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

December 30, 2021

Status Verified

December 1, 2021

Enrollment Period

12 months

First QC Date

December 21, 2021

Last Update Submit

December 29, 2021

Conditions

Esophagus Cancer

Keywords

Esophagus CancerPhotodynamics TherapyLaser dose

Outcome Measures

Primary Outcomes (2)

  • 1 month objective response rate

    Grade 3-4 dysphagia accounted

    1 month after photodynamic irradiation

  • 3 month objective response rate

    Grade 3-4 dysphagia accounted

    3 month after photodynamic irradiation

Secondary Outcomes (1)

  • 3 month Quality of Life score

    3 month after photodynamic irradiation

Study Arms (2)

single irradiation group

EXPERIMENTAL

46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2

Combination Product: single irradiation

Double irradiation group

ACTIVE COMPARATOR

46-48h, 72h after photosensitizer injection, divided into two irradiation times: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2;Power density: 200mW·cm-2, irradiation time: 300s, volume density: 60 J·cm-2.

Combination Product: Double irradiation

Interventions

single irradiationCOMBINATION_PRODUCT

46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2

single irradiation group
Double irradiationCOMBINATION_PRODUCT

46-48h, 72h after photosensitizer injection, divided into two irradiation times: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2;Power density: 200mW·cm-2, irradiation time: 300s, volume density: 60 J·cm-2.

Double irradiation group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • esophagus cancer
  • years old
  • grade 3-4 dysphagia （Stoller classification）
  • Non-eradicative second-line treatment

You may not qualify if:

  • Ulcerative tumor
  • Esophageal stenosis caused by radiotherapy
  • Survival is less than 3 months
  • Patients known to be allergic to photosensitizers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology

Luoyang, Henan, 471003, China

Location

Related Publications (6)

  • 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.

    PMID: 32578508BACKGROUND

  • 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.

    PMID: 23019392BACKGROUND

  • Liu H, Liu Y, Wang L, Ruan X, Wang F, Xu D, Zhang J, Jia X, Liu D. Evaluation on Short-Term Therapeutic Effect of 2 Porphyrin Photosensitizer-Mediated Photodynamic Therapy for Esophageal Cancer. Technol Cancer Res Treat. 2019 Jan 1;18:1533033819831989. doi: 10.1177/1533033819831989.

    PMID: 30885065BACKGROUND

  • Lee HH, Choi MG, Hasan T. Application of photodynamic therapy in gastrointestinal disorders: an outdated or re-emerging technique? Korean J Intern Med. 2017 Jan;32(1):1-10. doi: 10.3904/kjim.2016.200. Epub 2017 Jan 1.

    PMID: 28049283BACKGROUND

  • 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.

    PMID: 34202917RESULT

  • 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.

    PMID: 31156297RESULT

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Radiation

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

  • Shegan Gao, MD, PhD

    The First Affiliated Hospital of Clinical Medicine of Henan University of Science and Technology

    STUDY CHAIR

  • Tanyou Shan, MD, PhD

    The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology

    STUDY DIRECTOR

  • Caihong Dong, MD, PhD

    The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Wanying Li, MD

    The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Jiachun Sun, MD, PhD

    The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Mengxi Zhang, MD, PhD

    The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Xiaozhi Yuan, MD, PhD

    The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shegan Gao, MD, PhD

CONTACT

18638859977gsg112258@163.com

Tanyou Shan, MD, PhD

CONTACT

18537976669shantanyoudoctor@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2021

First Posted

December 30, 2021

Study Start

January 1, 2022

Primary Completion

December 31, 2022

Study Completion

June 30, 2023

Last Updated

December 30, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)