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

Study Overview
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Brief Summary
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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.

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

Conditions
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Esophageal Obstruction

Intervention / Treatment
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* Other: EGCG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EGCG application<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 8 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 8 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 8 days post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 8 days | 
| Symptom objective response rate | choking and pain when swallowing was assessed by NRS | baseline and up to 8 days post-treatment | 
| Weight change |  | baseline and up to 8 days post-treatment | 
| change in blood biochemical indicators | This will be determined by prealbumin and albumin values | baseline and up to 8 days post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EGCG, Esophageal obstruction, Supportive and Symptomatic Management