Study of Epigallocatechin-3-gallate (EGCG) for Supportive and Symptomatic Management in Patients With Esophageal Cancer

Phase 1

Completed

• Conditions: Esophageal Obstruction

• Registration Number: NCT05039983
• Lead Sponsor: Shandong Cancer Hospital and Institute

Brief Summary

The main symptom of patients with advanced esophageal cancer is eating obstruction. In clinical practice, patients need to wait for a long time before anti-tumor treatment, which will lead to a rapid decline in the quality of life and nutritional status of patients, and severe patients sometimes need to place nasointestinal feeding tubes or endoscopic stents. EGCG has been shown to have antioxidant, anti-inflammatory and anti-tumor effects . The complex effects of EGCG may improve esophageal obstruction during the waiting period before antineoplastic therapy. The purpose of this phase I study was to explore the safety, recommended dose and preliminary efficacy of EGCG solution in the treatment of esophageal obstruction.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-20
• Study First Submitted: 2021-08-22
• Study First Submitted QC: 2021-09-03
• Study First Posted: 2021-09-10
• Primary Completion: 2023-12-27
• Study Completion: 2024-01-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD)	baseline and up to 7 days post-treatment	the toxicities will be reported by describing Adverse Events (AE) per CTCAE v5.0, by dose level, and type and grade of toxicity
Recommended phase 2 dose (RP2D)	baseline and up to 7 days post-treatment	the toxicities will be reported by describing Adverse Events (AE) per CTCAE v5.0, by dose level, and type and grade of toxicity
Dose limiting toxicity (DLT)	baseline and up to 7 days post-treatment	the toxicities will be reported by describing Adverse Events (AE) per CTCAE v5.0, by dose level, and type and grade of toxicity

Secondary Outcome Measures

Name	Time	Method
change in blood biochemical indicators	baseline and up to 8 days post-treatment	This will be determined by prealbumin and albumin values
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
Symptom objective response rate	baseline and up to 7 days post-treatment	choking and pain when swallowing was assessed by Stooler's dysphagia score and NRS

Trial Locations

Locations (1)

Shan Dong cancer hospital and institute; 🇨🇳 Jinan, Shandong, China