Esophagus CancerNCT05174117
Influence of Different Light Dose on the Adverse Effect of Swallowing for Esophageal Carcinoma
A study testing single irradiation and Double irradiation in people with Esophagus Cancer, run by The First Affiliated Hospital of Henan University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Esophagus Cancer
- What is being tested?
- single irradiation and Double irradiation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Jun 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- esophagus cancer
- 18-80 years old
- grade 3-4 dysphagia （Stoller classification）
- Non-eradicative second-line treatment
Who cannot join
- Ulcerative tumor
- Esophageal stenosis caused by radiotherapy
- Survival is less than 3 months
- Patients known to be allergic to photosensitizers
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
Luoyang, Henan, 471003
About this study
Official title: A Phase III Randomized Controlled Study of the Effect of Different Light Doses on Adverse Outcomes of Swallowing in Esophageal Cancer
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.
Read the detailed description
Background: Photodynamic therapy (PDT) is one of the effective means for the control of esophageal stenosis in advanced esophageal cancer, among which the dose intensity of laser irradiation is one of the factors affecting the efficacy. This study aims to pursue the appropriate dose of light.
Aim: To compare the efficacy and safety of two groups of different laser irradiation doses for advanced esophageal cancer and esophageal stricture.
Methods: Fifty-seven patients were recruited for this study and randomly divided into two groups: single irradiation group and reirradiation group.Single irradiation group: 46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2;Double irradiation group: 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.
Primary endpoints: ORR rates at 1 and 3 months, the quality of life
- Conditions
- Esophagus Cancer
- Being tested
- single irradiation, Double irradiation
- Keywords
- Esophagus Cancer, Photodynamics Therapy, Laser dose
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single irradiationCombination product
46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2
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.
| Study group | Role | What they receive |
|---|---|---|
| single irradiation group | Experimental | 46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2 Receives: 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. Receives: Combination Product: Double irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 month objective response rate
Grade 3-4 dysphagia accounted
Measured: 1 month after photodynamic irradiation
3 month objective response rate
Grade 3-4 dysphagia accounted
Measured: 3 month after photodynamic irradiation
Secondary outcomes (1)
3 month Quality of Life score
Measured: 3 month after photodynamic irradiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start1 Jan 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Esophagus CancerStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 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 of Clinical Medicine of Henan University of Science and TechnologyTanyou Shan, MD, PhD, Study director, The First Affiliated Hospital and Clinical Medicine of Henan University of Science and TechnologyCaihong Dong, MD, PhD, Principal investigator, The First Affiliated Hospital and Clinical Medicine of Henan University of Science and TechnologyWanying Li, MD, Principal investigator, The First Affiliated Hospital and Clinical Medicine of Henan University of Science and TechnologyJiachun Sun, MD, PhD, Principal investigator, The First Affiliated Hospital and Clinical Medicine of Henan University of Science and TechnologyMengxi Zhang, MD, PhD, Principal investigator, The First Affiliated Hospital and Clinical Medicine of Henan University of Science and TechnologyXiaozhi Yuan, MD, PhD, Principal investigator, The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174117
- Sponsor's protocol ID
- ECPDT-001
- Status last verified
- Dec 2021
- First submitted
- 21 Dec 2021
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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 23019392Liu 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.
PubMed 30885065Lee 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.
PubMed 28049283Yano 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 31156297
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Controlled Study of the Effect of Different Light Doses on Adverse Outcomes of Swallowing in Esophageal Cancer
- ClinicalTrials.gov ID
- NCT05174117
- Acronym / sponsor ID
- ECPDT-001
- Conditions
- Esophagus Cancer
- Keywords
- Esophagus Cancer, Photodynamics Therapy, Laser dose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Henan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 30 Dec 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 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.
Detailed description
Background: Photodynamic therapy (PDT) is one of the effective means for the control of esophageal stenosis in advanced esophageal cancer, among which the dose intensity of laser irradiation is one of the factors affecting the efficacy. This study aims to pursue the appropriate dose of light.
Aim: To compare the efficacy and safety of two groups of different laser irradiation doses for advanced esophageal cancer and esophageal stricture.
Methods: Fifty-seven patients were recruited for this study and randomly divided into two groups: single irradiation group and reirradiation group.Single irradiation group: 46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2;Double irradiation group: 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.
Primary endpoints: ORR rates at 1 and 3 months, the quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single irradiation group | Experimental | Combination Product: single irradiation46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2 |
| Double irradiation group | Active comparator | Combination Product: Double irradiation46-48h, 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- esophagus cancer
- 18-80 years old
- grade 3-4 dysphagia （Stoller classification）
- Non-eradicative second-line treatment
Key exclusion criteria (4 listed)
- Ulcerative tumor
- Esophageal stenosis caused by radiotherapy
- Survival is less than 3 months
- Patients known to be allergic to photosensitizers
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 |
|---|---|---|
| single irradiation46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2 | Combination product | single irradiation group |
| Double irradiation46-48h, 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 group |
Primary outcome
1 month objective response rate
Time frame: 1 month after photodynamic irradiation
Grade 3-4 dysphagia accounted
3 month objective response rate
Time frame: 3 month after photodynamic irradiation
Grade 3-4 dysphagia accounted
1 secondary outcome
3 month Quality of Life score
Time frame: 3 month after photodynamic irradiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
- 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 30885065Liu 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.
- Background: PubMed 28049283Lee 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.
- Results publication: 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.
- Results publication: 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.
- Individual participant dataSharing planned: No
Related trials for Esophagus Cancer
RecruitingPhase 2/3
A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (ROSETTA Gastric-204)
Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 4
Efficacy of Potassium-Competitive Acid Blockers in Barrett's Esophagus (PCAB BE Study)
Barrett Esophagus
RecruitingPhase 1/2
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma
RecruitingPhase 1
Phase 1 Study of PF-08046033 in Advanced Solid Tumors
Non-Small-Cell Lung, Esophageal 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.
Shegan Gao, MD, PhD study chair
The First Affiliated Hospital of Clinical Medicine of Henan University of Science and Technology
Tanyou Shan, MD, PhD study director
The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
Caihong Dong, MD, PhD principal investigator
The First Affiliated Hospital and Clinical Medicine of Henan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single irradiation and Double irradiation in people with Esophagus Cancer, run by The First Affiliated Hospital of Henan University of Science and Technology 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 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 30 Dec 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 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?
1 month objective response rate (time frame: 1 month after photodynamic irradiation). The study lists 2 primary outcomes in all. 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 NCT05174117, which also lists 6 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 30 Dec 2021.