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Hematoporphyrin Photodynamic Therapy for Esophageal Cancer

StatusEnrolling by Invitation
PhasePhase 4
Started2024-09-18
View on ClinicalTrials.gov ↗

Amendment history

2026-05-19
Not Yet Recruiting→Enrolling by Invitation Study Identification, Study Status, Oversight, Contacts/Locations v4
Trial statusNot Yet Recruiting→Enrolling by Invitation
Study sitescontacts updated at 1 of 1 site
2024-09-19
Study Identification, Study Status, Study Design, Outcome Measures, Eligibility v3
PhasePhase 2→Phase 4
Eligibility criteria+2,594 characters
Inclusion Criteria: Adult1. patientsAge agedbetween 18- and 80 years (inclusive of both 18 and 80 years), with recurrentno restrictions on gender. 2.Patients with esophageal squamous cell carcinoma who have undergone prior treatment, including radiotherapy, chemotherapy, immunotherapy, or surgical intervention (esophagectomy or endoscopic esophageal cancer surgery), with pathological confirmation of recurrence or residual disease (at least of high-grade intraepithelial neoplasia or above). 3.Patients with superficial esophageal cancer, where the primary lesion is located in the mucosal or subm [...] [...]
2024-09-12
Study Identification, Study Status, Oversight, Contacts/Locations v2
Primary completion date2027-04-30→2027-09-30
Completion date2027-12-01→2030-12-01
Start date2024-07-01→2024-09-18
Study sites0→1
2024-06-27
Study Status, Study Description, Arms and Interventions, Outcome Measures v1
Start date2024-05-31→2024-07-01
Interventionsphotodynamic therapy (Drug)→photodynamic therapy (Procedure)
Secondary endpointsdetails revised at 2 of 5 entries
2024-05-26
Original filing
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 3mg/kg 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
Trial Details
NCT Number NCT06437288
Lead Sponsor Sun Yat-sen University
Conditions Esophageal Cancer, Photodynamic Therapy
Enrollment 198 participants
Start Date 2024-09-18
Primary Completion 2027-09-30 (estimated)
Study Completion 2030-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-22