Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06398405

A Phase II Clinical Study of Epigallocatechin-3-gallate in Patients With Esophageal Squamous Cancer

Led by Shandong Cancer Hospital and Institute · Updated on 2024-05-03

72

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The investigators conduct this phase II study to evaluate safety and effectiveness of EGCG in patients with dysphagia. Swallowing-related dysphagia and pain scores were recorded using the numerical rating scale (NRS) daily . Barium meal radiography was utilized to measure the luminal size and the length of the lesion area both before and after a week of EGCG treatment. The scales are translated into Chinese and guides in Chinese are developed instructing how to use the scales and perform the assessments.

CONDITIONS

Official Title

A Phase II Clinical Study of Epigallocatechin-3-gallate in Patients With Esophageal Squamous Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed pathological esophageal squamous cell carcinoma
  • 18 years old or older
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
  • No previous anti-tumor treatment
  • No esophageal bleeding or fistula
  • Adequate hemocyte count and normal liver and kidney function
  • Esophageal obstruction classified as grade 2 or grade 3 by Stooler's dysphagia score
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Known allergy or hypersensitivity to any kind of green tea extract
  • Placement of small intestinal feeding tube or previous endoscopic stent treatment
  • Unable or unwilling to take oral liquids

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shandong Cancer Hospital

Jinan, Shandong, China, 250117

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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