Therapeutic Effectiveness of Hematoporphyrin Injection Based Photodynamic Therapy in Post-Treatment Recurrent or Residual Superficial Esophageal Cancer: A Prospective, Single-Arm, Multicentric Study

2024-FXY-183

The goal of this clinical trial is to evaluate the effectiveness of photodynamic therapy using hematoporphyrin injection in treating recurrent or residual superficial esophageal cancer. The primary purpose is to assess the ability of this intervention to achieve complete response in these patients. The main question it aims to answer is: - What is the complete response rate at day 28 post-treatment with PDT using hematoporphyrin injection in patients with recurrent or residual superficial esophageal cancer? There is no comparison group in this single-arm study. Participants will: * Be adults aged 18-80 with recurrent or residual superficial esophageal cancer after prior treatment. * Receive an intravenous infusion of hematoporphyrin injection at a dose of 3mg/kg over 60 minutes. * Undergo 630nm laser irradiation 48-72 hours after the infusion. * Be assessed for complete response at day 28 post-treatment, as well as progression-free survival, overall survival, swallowing function, quality of life, and adverse events throughout the study.

2024-05-31

2027-04-30

2027-12-01

Not yet recruiting

Early phase I

198

Inclusion Criteria: * Adult patients aged 18-80 with recurrent or residual superficial esophageal cancer after prior treatment. Exclusion Criteria: * Known hypersensitivity, severe comorbidities, pregnancy, etc.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-Stage Phase II Clinical Trials', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 198, 'type': 'ESTIMATED'}}

2024-05-31