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

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.

Study Overview

• Status: Completed
• Conditions: Esophageal Obstruction
• Intervention / Treatment: Other: EGCG

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Zhao Hanxi, M.D, PhD.; Phone Number: 0086053167626142; Email: 171459576@qq.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shan Dong cancer hospital and institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: EGCG application; We have chosen a dose of 880 umol/L as the lower limit for this phase I study by referring to previous studies. Six dose levels for EGCG were defined as following: 880, 1760, 2640, 3430, and 4400 umol/L per dose. Dose escalation proceeded according to a standard phase I design with three patients initially treated on each tier. If, on any dose tier of EGCG, two of three patients or two of six patients experienced a more than grade II toxicity due to EGCG, dose escalation of EGCG would cease. The maximally tolerated dose (MTD) was defined as the highest dose with fewer than one-third of patients experiencing a dose-limiting toxicity (DLT) due to EGCG. EGCG solution was given continuously for 7 days before anti-tumor treatment.

Other: EGCG; EGCG use various concentrations dissolved in 0.9% saline solution three times a day. A new batch is made up each time. For esophageal application, repeated swallowing of 30 ml of the EGCG solution is indispensable to assure the prolonged presence of drug the esophageal walls.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shandong Cancer Hospital and Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2021
• Primary Completion (Actual): December 27, 2023
• Study Completion (Actual): January 2, 2024

Study Registration Dates

• First Submitted: August 22, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (Actual): September 10, 2021

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: EGCG; Esophageal obstruction; Supportive and Symptomatic Management
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: GTEEC2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No