NCT06437288

Hematoporphyrin Photodynamic Therapy for Esophageal Cancer

Real-World Study of Hematoporphyrin Injection-Based Photodynamic Therapy in Patients with Recurrent or Residual Superficial Esophageal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 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

Conditions

• Esophageal Cancer
• Photodynamic Therapy

Interventions

Type	Name	Description
PROCEDURE	photodynamic therapy	Receive an intravenous infusion of hematoporphyrin injection

Timeline

• Start date: 2024-09-18
• Primary completion: 2027-09-30
• Completion: 2030-12-01
• First posted: 2024-05-31
• Last updated: 2024-09-23

Locations

1 site across 1 country: China