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Completed

NCT Number: NCT05039983

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.

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Key information

Conditions

Esophageal Obstruction Airway Obstruction Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shan Dong cancer hospital and institute

Jinan, Shandong, 250117, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Dose limiting toxicity (DLT)

    Time frame: baseline and up to 7 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

  2. Maximum tolerated dose (MTD)

    Time frame: baseline and up to 7 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

  3. Recommended phase 2 dose (RP2D)

    Time frame: baseline and up to 7 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 outcomes

  1. Imaging objective response rate

    Time frame: Change from Baseline esophageal stenosis size at 7 days

    Response rate of esophageal stenosis was determined by X-ray barium meal examination and/or contrast-enhanced CT

  2. Symptom objective response rate

    Time frame: baseline and up to 7 days post-treatment

    choking and pain when swallowing was assessed by Stooler's dysphagia score and NRS

  3. change in blood biochemical indicators

    Time frame: baseline and up to 8 days post-treatment

    This will be determined by prealbumin and albumin values

Sponsors and collaborators

Lead sponsor

Shandong Cancer Hospital and Institute

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Sep 10, 2021
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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