RECRUITINGPhase 2INTERVENTIONAL

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

Efficacy and Safety of Epigallocatechin-3-gallate, an Important Polyphenolic That Originates From Tea, in Patients With Esophageal Squamous Cancer: A Phase II Trial

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

OTHER

Epigallocatechin-3-gallate

Epigallocatechin-3-gallate is administered in a solution with a concentration of 4400 umol/L

Locations (1)

Shandong Cancer Hospital

Jinan, Shandong, China