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

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

Recruiting
18 years and older
All
Phase 2

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Overview

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.

Eligibility

Inclusion Criteria:

  • confirmed pathological esophageal squamous cell carcinoma
  • ≥18 years old
  • the Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
  • no previous anti-tumor treatment
  • no esophageal bleeding or fistula
  • adequate hemocyte count, normal hepatic and renal functions
  • Esophageal obstruction classified as grade 2 or grade 3 according to Stooler's dysphagia score

Exclusion Criteria:

  • lactating or pregnant women
  • known hypersensitivity or allergy to any kind green tea extract
  • placement of small intestinal feeding tube or endoscopic stent treatment
  • unable or refusing to take oral liquids

Study details
    Esophageal Cancer
    Dysphagia
    Esophageal
    Epigallocatechin Gallate

NCT06398405

Shandong Cancer Hospital and Institute

19 May 2024

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