## Protocol Section
### Identification Module
**NCT ID:** NCT06437288

**Brief Title:** Hematoporphyrin Photodynamic Therapy for Esophageal Cancer

**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

#### Organization Study ID Info
**ID:** 2024-FXY-183
#### Organization
**Class:** OTHER
**Full Name:** Sun Yat-sen University
### Status Module
#### Completion Date
**Date:** 2027-12-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-26

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-04-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Sun Yat-sen University

#### Responsible Party

**Investigator Affiliation:** Sun Yat-sen University

**Investigator Full Name:** Jian-jun Li

**Investigator Title:** Prefessor, Endoscopy Department Administrative Director

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- Esophageal Cancer

- Photodynamic Therapy

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Single-Stage Phase II Clinical Trials

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 198

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Drug: photodynamic therapy

**Label:** photodynamic therapy

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- photodynamic therapy

**Description:** Receive an intravenous infusion of hematoporphyrin injection

**Name:** photodynamic therapy

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The proportion of patients showing a complete disappearance of the tumor following the treatment, as assessed by EUS on day 28

**Measure:** The complete response rate evaluated by endoscopic ultrasound (EUS)

**Time Frame:** 28 days after the treatment.

#### Secondary Outcomes

**Description:** 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.

**Measure:** Progression free survival

**Time Frame:** 3 years

**Description:** length of time from the start of the treatment until the death of the patient, regardless of the cause.

**Measure:** Overall survival

**Time Frame:** 3 years

**Description:** Adverse events of the treatment.

**Measure:** Adverse events

**Time Frame:** 1 month after the treatment

**Description:** EORTC QLQ-C30 () is a 30-item questionnaire that assesses the quality of life of cancer patients.

**Measure:** Quality of life evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC QLQ-C30)

**Time Frame:** 0.5 year; 1 year; 3 year

**Description:** 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.

**Measure:** Stooler's dysphagia grading

**Time Frame:** 0.5 year; 1 year; 3 year

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** lijj@sysucc.org.cn

**Name:** Jianjun Li, Doctor

**Phone:** 02087343009

**Phone Ext:** 02087343009

**Role:** CONTACT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000006258

- Term: Head and Neck Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000004935

- Term: Esophageal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M8088

- Name: Esophageal Neoplasms

- Relevance: HIGH

- As Found: Esophageal Cancer

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M9348

- Name: Head and Neck Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8085

- Name: Esophageal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T2141

- Name: Esophageal Cancer

- Relevance: HIGH

- As Found: Esophageal Cancer

### Condition Browse Module - Meshes

- ID: D000004938

- Term: Esophageal Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: Derm

- Name: Dermatologic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M9502

- Name: Hematoporphyrins

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
