Hematoporphyrin Photodynamic Therapy for Esophageal Cancer

Real-World Study of Hematoporphyrin Injection-Based Photodynamic Therapy in Patients With Recurrent or Residual Superficial Esophageal Cancer

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Esophageal Cancer; Photodynamic Therapy
• Intervention / Treatment: Procedure: photodynamic therapy

• Study Type: Interventional
• Enrollment (Estimated): 198
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Endoscopic Department of Sun Yat-Sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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:

1. Known allergy to the study medication or related drugs.
2. Patients who have not recovered from the toxicities associated with prior radiotherapy or chemotherapy treatments.
3. Previous treatment with other photosensitizers that was ineffective, or subjects who have received a photosensitizer treatment within 12 months prior to enrollment.
4. Use of other photosensitizing medications within 4 weeks prior to administration, such as tetracycline antibiotics, sulfonamides, and phenothiazines.
5. Neutrophil count <1.5×10^9 /L, platelet count <100×10^9 /L, or hemoglobin <100 g/L.
6. Serum creatinine ≥3 times the upper limit of normal or creatinine clearance <60 ml/min/1.73m^2; ALT or AST >3 times the upper limit of normal; or in the case of liver metastasis, ALT or AST >5 times the upper limit of normal; serum bilirubin >3 times the upper limit of normal.
7. Presence of severe comorbid conditions, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, and uncontrolled hypertension.
8. HIV, HCV, syphilis infection, or positive for both hepatitis B surface antigen and e antigen.
9. Active esophageal inflammation (especially visible active ulcers, hyperemia, necrosis, etc. under endoscopy) or clinically significant active infection symptoms.
10. Pregnant or lactating women, and sexually active subjects of childbearing potential (including males) who refuse to use appropriate contraceptive measures during the study.
11. Active bleeding or bleeding diathesis (abnormal coagulation mechanism).
12. Severe physical or mental illness that may affect treatment, assessment, or compliance with the study protocol.
13. Concurrent second primary tumor undergoing treatment.
14. Single lesion greater than 5cm in length.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: photodynamic therapy; Receive an intravenous infusion of hematoporphyrin injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	56 days after the treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years
Overall survival	length of time from the start of the treatment until the death of the patient, regardless of the cause.	3 years
Adverse events	Adverse events of the treatment.	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.	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.	0.5 year; 1 year; 3 year

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: May 26, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms; Therapeutics; Drug Therapy; Combined Modality Therapy; Phototherapy; Photochemotherapy
• Other Study ID Numbers: 2024-FXY-183

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No