Hematoporphyrin Photodynamic Therapy for Esophageal Cancer
- Conditions
- Photodynamic TherapyEsophageal Cancer
- Interventions
- Procedure: photodynamic therapy
- Registration Number
- NCT06437288
- Lead Sponsor
- Sun Yat-sen University
- 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 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 198
- Adult patients aged 18-80 with recurrent or residual superficial esophageal cancer after prior treatment.
- Known hypersensitivity, severe comorbidities, pregnancy, etc.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description photodynamic therapy photodynamic therapy 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.
- Primary Outcome Measures
Name Time Method The complete response rate evaluated by endoscopic ultrasound (EUS) 56 days after the treatment. The proportion of patients showing a complete disappearance of the tumor following the treatment, as assessed by EUS on day 56
- Secondary Outcome Measures
Name Time Method Overall survival 3 years length of time from the start of the treatment until the death of the patient, regardless of the cause.
Progression free survival 3 years Length of time during and after the treatment of a disease, in which a patient lives with the disease but it does not get worse.
Adverse events 1 month after the treatment Adverse events of the treatment.
Quality of life evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC QLQ-C30) 0.5 year; 1 year; 3 year The Quality of life evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC QLQ-C30) assesses cancer patients' quality of life with 30 items in functional and symptom scales scored 1-3, and a global health scale scored 1-7. Higher scores on functional/global health scales indicate better quality of life, while higher symptom scores mean worse outcomes. The scale's minimum and maximum scores vary by the number of items in each scale, with transformation to a 0-100 scale for standardization.
Stooler's dysphagia grading 0.5 year; 1 year; 3 year Stooler's dysphagia grading, in its full title, is known as the Stooler's Dysphagia Scale. This scale is used to assess the severity of dysphagia, which is difficulty or discomfort in swallowing. The Stooler's scale categorizes dysphagia into five grades, ranging from Grade 0 to Grade 4, with higher grades indicating more severe dysphagia.
Here is a breakdown of the Stooler's Dysphagia Scale:
Grade 0: No difficulty in swallowing. Grade 1: Occasional difficulty in swallowing solids. Grade 2: Occasional difficulty in swallowing liquids and frequent difficulty with solids.
Grade 3: Complete inability to swallow solids and frequent difficulty with liquids.
Grade 4: Inability to swallow any oral intake. In this scale, a lower grade indicates a better outcome, as it signifies less difficulty in swallowing. Conversely, a higher grade indicates a worse outcome, with Grade 4 being the most severe, indicating the inability to swallow anything orally.
Trial Locations
- Locations (1)
Endoscopic Department of Sun Yat-Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China