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NOT YET RECRUITING
NCT06437288
PHASE4

Hematoporphyrin Photodynamic Therapy for Esophageal Cancer

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

198

Start Date

2024-09-18

Completion Date

2030-12-01

Last Updated

2024-09-23

Healthy Volunteers

No

Interventions

PROCEDURE

photodynamic therapy

Receive an intravenous infusion of hematoporphyrin injection

Locations (1)

Endoscopic Department of Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China