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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06398405
• Other study ID #: GTEEC2024
• Status: Recruiting
• Phase: Phase 2
• Start date: April 22, 2024
• Est. completion date: May 22, 2026

Study information

• Verified date: May 2024
• Source: Shandong Cancer Hospital and Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: May 22, 2026
• Est. primary completion date: April 22, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia, Esophageal
• Epigallocatechin Gallate
• Esophageal Cancer
• Esophageal Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Shandong Cancer Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Choking symptom objective response rate	Choking when swallowing was assessed by Stooler's dysphagia score (0-4, with 0 being none and 4 being completely unable to feed orally)	baseline and up to 7 days post-treatment
Primary	Pain symptom objective response rate	Pain when swallowing was assessed by numerical rating scale (0-5, with 0 being none and 5 being worst pain imaginable)	baseline and up to 7 days post-treatment
Primary	Imaging objective response rate	Response rate of esophageal stenosis was determined by X-ray barium meal examination and/or contrast-enhanced CT	Change from Baseline esophageal stenosis size at 7 days
Secondary	prealbumin change	The prealbumin values were tested by biochemical analysis	baseline and up to 7 days post-treatment
Secondary	Albumin change	The albumin values were tested by biochemical analysis	baseline and up to 7 days post-treatment
Secondary	Number of Participants with Adverse Events	participants will be followed for the duration of EGCG treatment	baseline and up to 7 days post-treatment