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

Esophageal Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05039983
• Other study ID #: GTEEC2021
• Status: Completed
• Phase: Phase 1
• Start date: August 20, 2021
• Est. completion date: January 2, 2024

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2, 2024
• Est. primary completion date: December 27, 2023
• 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

• Esophageal Neoplasms
• Esophageal Obstruction

Intervention

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.

Locations

Country	Name	City	State
China	Shan Dong cancer hospital and institute	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	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
Primary	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
Primary	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	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	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
Secondary	change in blood biochemical indicators	This will be determined by prealbumin and albumin values	baseline and up to 8 days post-treatment