Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06437288
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-05-21
Brief Title:
Hematoporphyrin Photodynamic Therapy for Esophageal Cancer
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Real-World Study of Hematoporphyrin Injection-Based Photodynamic Therapy in Patients with Recurrent or Residual Superficial Esophageal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the present clinical trial is to assess the efficacy of photodynamic therapy PDT employing hematoporphyrin injection in the management of recurrent or residual superficial esophageal carcinoma The principal objective is to determine the capability of this therapeutic modality to elicit a complete response in the patient cohort under investigation
The central research question that this study seeks to address is as follows
What is the rate of complete response at day 28 following treatment with photodynamic therapy utilizing hematoporphyrin injection in patients suffering from recurrent or residual superficial esophageal cancer This study is designed as a single-arm trial devoid of a control or comparison group
Eligible participants will meet the following criteria
They will be adult patients aged between 18 and 80 years who have experienced recurrence or retention of superficial esophageal cancer subsequent to prior therapeutic interventions
They will receive an intravenous administration of hematoporphyrin injection at a dosage of 3mgkg over a duration of 60 minutes
They will undergo irradiation with a 630nm laser which will be administered 48-72 hours post-infusion
Their response to treatment will be evaluated at day 28 post-therapy with assessments encompassing complete response progression-free survival overall survival swallowing functionality quality of life and the incidence of adverse events throughout the duration of the study
The central research question that this study seeks to address is as follows
What is the rate of complete response at day 28 following treatment with photodynamic therapy utilizing hematoporphyrin injection in patients suffering from recurrent or residual superficial esophageal cancer This study is designed as a single-arm trial devoid of a control or comparison group
Eligible participants will meet the following criteria
They will be adult patients aged between 18 and 80 years who have experienced recurrence or retention of superficial esophageal cancer subsequent to prior therapeutic interventions
They will receive an intravenous administration of hematoporphyrin injection at a dosage of 3mgkg over a duration of 60 minutes
They will undergo irradiation with a 630nm laser which will be administered 48-72 hours post-infusion
Their response to treatment will be evaluated at day 28 post-therapy with assessments encompassing complete response progression-free survival overall survival swallowing functionality quality of life and the incidence of adverse events throughout the duration of the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None