Hematoporphyrin Photodynamic Therapy for Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06437288
• Other study ID #: 2024-FXY-183
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 31, 2024
• Est. completion date: December 1, 2027

Study information

• Verified date: May 2024
• Source: Sun Yat-sen University
• Contact: Jianjun Li, Doctor
• Phone: 02087343009
• Email: lijj[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 198
• Est. completion date: December 1, 2027
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Photodynamic Therapy

Intervention

Drug:
• photodynamic therapy
Receive an intravenous infusion of hematoporphyrin injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 28	28 days after the treatment.
Secondary	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
Secondary	Overall survival	length of time from the start of the treatment until the death of the patient, regardless of the cause.	3 years
Secondary	Adverse events	Adverse events of the treatment.	1 month after the treatment
Secondary	Quality of life evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC QLQ-C30)	EORTC QLQ-C30 () is a 30-item questionnaire that assesses the quality of life of cancer patients.	0.5 year; 1 year; 3 year
Secondary	Stooler's dysphagia grading	Stooler's dysphagia grading is a clinical method used to categorize the severity of swallowing difficulties in patients with esophageal disorders, including esophageal cancer. It is based on the patient's ability to swallow liquids, semi-solids, and solids.	0.5 year; 1 year; 3 year