A Phase II Clinical Study of Epigallocatechin-3-gallate in Patients With Esophageal Squamous Cancer
Trial Parameters
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Brief Summary
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 Criteria
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