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

NCT05039983 | Completed Phase 1

• 1 other identifier: GTEEC2021
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Obstruction

Keywords

EGCG; Esophageal obstruction; Supportive and Symptomatic Management

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Imaging objective response rate

  Change from Baseline esophageal stenosis size at 7 days

• Symptom objective response rate

  baseline and up to 7 days post-treatment

• change in blood biochemical indicators

  baseline and up to 8 days post-treatment

Study Arms (1)

EGCG application

EXPERIMENTAL

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

Interventions

EGCG OTHER

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.

EGCG application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Shan Dong cancer hospital and institute

Jinan, Shandong, 250117, China

Location

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: September 10, 2021
• Study Start: August 20, 2021
• Primary Completion: December 27, 2023
• Study Completion: January 2, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

CN (1)