Endoscopic Department of Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
NCT Number: NCT06437288
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
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 4
Guangzhou, Guangdong, 510060, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Time frame: 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
Time frame: 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.
Time frame: 3 years
length of time from the start of the treatment until the death of the patient, regardless of the cause.
Time frame: 1 month after the treatment
Adverse events of the treatment.
Time frame: 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.
Time frame: 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.
Sun Yat-sen University
Other
Real-World Study of Hematoporphyrin Injection-Based Photodynamic Therapy in Patients With Recurrent or Residual Superficial Esophageal Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02427269
Barrett Esophagus, Barrett's Esophagus
Chapel Hill, North Carolina, United States
View Trial DetailsNCT07642401
Digestive System Diseases, Digestive System Neoplasms
Anyang, Henan, China
View Trial DetailsNCT06862479
Anastomotic Leak, Anastomotic Leak Esophagus
Lisbon, Lisbon District, Portugal
View Trial DetailsNCT07371247
CtDNA, Digestive System Diseases
Nanjing, Jiangsu, China
View Trial Details