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

Sponsor

Shandong Cancer Hospital and Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05039983

Collaborator

(none)

Enrollment

Location

Arm

3.1

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Obstruction	Other: EGCG	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 20, 2021

Anticipated Primary Completion Date :

Oct 23, 2021

Anticipated Study Completion Date :

Nov 23, 2021

Arms and Interventions

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 grade III or IV 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 8 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 10 ml of the EGCG solution is indispensable to assure the prolonged presence of drug the esophageal walls.

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 grade III or IV 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 8 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 10 ml of the EGCG solution is indispensable to assure the prolonged presence of drug the esophageal walls.

Outcome Measures

Primary Outcome Measures

Dose limiting toxicity (DLT) [baseline and up to 8 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
Maximum tolerated dose (MTD) [baseline and up to 8 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 8 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

Imaging objective response rate [Change from Baseline esophageal stenosis size at 8 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 8 days post-treatment]
choking and pain when swallowing was assessed by NRS
Weight change [baseline and up to 8 days post-treatment]
change in blood biochemical indicators [baseline and up to 8 days post-treatment]
This will be determined by prealbumin and albumin values

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 CTCAE 5.0

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shan Dong cancer hospital and institute	Jinan	Shandong	China	250117

Sponsors and Collaborators

Shandong Cancer Hospital and Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Han Xi Zhao, Principal Investigator, Shandong Cancer Hospital and Institute

ClinicalTrials.gov Identifier:

NCT05039983

Other Study ID Numbers:

GTEEC2021

First Posted:

Sep 10, 2021

Last Update Posted:

Sep 10, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Han Xi Zhao, Principal Investigator, Shandong Cancer Hospital and Institute

EGCG

Esophageal obstruction

Supportive and Symptomatic Management

Additional relevant MeSH terms:

Esophageal Neoplasms

Study Results

No Results Posted as of Sep 10, 2021