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

Primary Purpose

Esophageal Obstruction

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EGCG
Sponsored by
Shandong Cancer Hospital and Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Obstruction focused on measuring EGCG, Esophageal obstruction, Supportive and Symptomatic Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Shan Dong cancer hospital and instituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EGCG application

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Imaging objective response rate
Response rate of esophageal stenosis was determined by X-ray barium meal examination and/or contrast-enhanced CT
Symptom objective response rate
choking and pain when swallowing was assessed by NRS
Weight change
change in blood biochemical indicators
This will be determined by prealbumin and albumin values

Full Information

First Posted
August 22, 2021
Last Updated
September 3, 2021
Sponsor
Shandong Cancer Hospital and Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05039983
Brief Title
Study of Epigallocatechin-3-gallate (EGCG) for Supportive and Symptomatic Management in Patients With Esophageal Cancer
Official Title
Study of Epigallocatechin-3-gallate (EGCG) for Supportive and Symptomatic Management in Patients With Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2021 (Actual)
Primary Completion Date
October 23, 2021 (Anticipated)
Study Completion Date
November 23, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong Cancer Hospital and Institute

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Obstruction
Keywords
EGCG, Esophageal obstruction, Supportive and Symptomatic Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EGCG application
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
EGCG
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dose limiting toxicity (DLT)
Description
the toxicities will be reported by describing Adverse Events (AE) per CTCAE v5.0, by dose level, and type and grade of toxicity
Time Frame
baseline and up to 8 days post-treatment
Title
Maximum tolerated dose (MTD)
Description
the toxicities will be reported by describing Adverse Events (AE) per CTCAE v5.0, by dose level, and type and grade of toxicity
Time Frame
baseline and up to 8 days post-treatment
Title
Recommended phase 2 dose (RP2D)
Description
the toxicities will be reported by describing Adverse Events (AE) per CTCAE v5.0, by dose level, and type and grade of toxicity
Time Frame
baseline and up to 8 days post-treatment
Secondary Outcome Measure Information:
Title
Imaging objective response rate
Description
Response rate of esophageal stenosis was determined by X-ray barium meal examination and/or contrast-enhanced CT
Time Frame
Change from Baseline esophageal stenosis size at 8 days
Title
Symptom objective response rate
Description
choking and pain when swallowing was assessed by NRS
Time Frame
baseline and up to 8 days post-treatment
Title
Weight change
Time Frame
baseline and up to 8 days post-treatment
Title
change in blood biochemical indicators
Description
This will be determined by prealbumin and albumin values
Time Frame
baseline and up to 8 days post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhao Hanxi, M.D, PhD.
Phone
0086053167626142
Email
171459576@qq.com
Facility Information:
Facility Name
Shan Dong cancer hospital and institute
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ligang Xing, M.D.
Phone
0086053167626819
Email
xinglg@medmail.com
First Name & Middle Initial & Last Name & Degree
Hanxi Zhao, M.D.
Phone
0086053167626995
Email
171459576@qq.com

12. IPD Sharing Statement

Learn more about this trial

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

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