A Phase 4 interventional study of photodynamic therapy in Esophageal Cancer and Photodynamic Therapy, sponsored by Sun Yat-sen University. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Sun Yat-sen University · Phase 4, Interventional, and Treatment
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
1,592 studies on the registry are indexed under Esophageal Neoplasms; 460 are open to participants now.
This study's planned enrollment of 198 is above the median of 58 across 1,170 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
Counted across the registry records on this site, refreshed daily.
1. Age between 18 and 80 years (inclusive of both 18 and 80 years), with no 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 submucosal layer, and the muscular layer is still intact, as indicated by ultrasound endoscopy and related examinations.
4.Subjects capable of tolerating general anesthesia. 5.Absence of severe hematological, coagulation, cardiac, pulmonary, hepatic, renal, or immunological abnormalities.
6.Voluntary consent to participate in the clinical trial after being fully informed about the purpose, process, potential risks, and benefits of the trial, including the subject's obligations.
Exclusion Criteria:
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.
Procedure: photodynamic therapy
Receive an intravenous infusion of hematoporphyrin injection
The complete response rate evaluated by endoscopic ultrasound (EUS)
The proportion of patients showing a complete disappearance of the tumor following the treatment, as assessed by EUS on day 56
Time frame: 56 days after the treatment.
Progression free survival
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.
Time frame: 3 years
Overall survival
length of time from the start of the treatment until the death of the patient, regardless of the cause.
Time frame: 3 years
Adverse events
Adverse events of the treatment.
Time frame: 1 month after 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)
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.
Time frame: 0.5 year; 1 year; 3 year
Stooler's dysphagia grading
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.
Time frame: 0.5 year; 1 year; 3 year
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Sun Yat-sen University