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

Phase 2

Recruiting

• Conditions: Esophageal Cancer; Dysphagia, Esophageal; Epigallocatechin Gallate
• Interventions: Other: Epigallocatechin-3-gallate

• Registration Number: NCT06398405
• Lead Sponsor: Shandong Cancer Hospital and Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-22
• Study First Submitted: 2024-04-29
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-02
• Last Update Submitted: 2024-05-02
• Study First Posted: 2024-05-03
• Last Update Posted: 2024-05-03
• Primary Completion: 2026-04-22
• Study Completion: 2026-05-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EGCG ARM	Epigallocatechin-3-gallate	Studies investigating EGCG (purity 95% by high-performance liquid chromatography, obtained from Zhejiang Ningbo HEP Biotech Co., Ltd.) utilized a concentration of 4400 umol/L dissolved in 0.9% saline solution, which is administered three times a day for 1 week. Freshly prepared each time, the EGCG was administered 10 minutes before meals. The repeated slow swallowing of 30 ml of the EGCG solution was essential to ensure sustained contact of the drug on the esophageal walls

Primary Outcome Measures

Name	Time	Method
Choking symptom objective response rate	baseline and up to 7 days post-treatment	Choking when swallowing was assessed by Stooler's dysphagia score (0-4, with 0 being none and 4 being completely unable to feed orally)
Imaging objective response rate	Change from Baseline esophageal stenosis size at 7 days	Response rate of esophageal stenosis was determined by X-ray barium meal examination and/or contrast-enhanced CT
Pain symptom objective response rate	baseline and up to 7 days post-treatment	Pain when swallowing was assessed by numerical rating scale (0-5, with 0 being none and 5 being worst pain imaginable)

Secondary Outcome Measures

Name	Time	Method
Albumin change	baseline and up to 7 days post-treatment	The albumin values were tested by biochemical analysis
prealbumin change	baseline and up to 7 days post-treatment	The prealbumin values were tested by biochemical analysis
Number of Participants with Adverse Events	baseline and up to 7 days post-treatment	participants will be followed for the duration of EGCG treatment

Trial Locations

Locations (1)

Shandong Cancer Hospital; 🇨🇳 Jinan, Shandong, China