A Phase II Clinical Study of Epigallocatechin-3-gallate in Patients With Esophageal Squamous Cancer
NCT ID: NCT06398405
Last Updated: 2024-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
72 participants
INTERVENTIONAL
2024-04-22
2026-05-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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EGCG ARM
Studies investigating EGCG (purity 95% by high-performance liquid chromatography, obtained from Zhejiang Ningbo HEP Biotech Co., Ltd.) utilized a concentration of 4400 umol/L dissolved in 0.9% saline solution, which is administered three times a day for 1 week. Freshly prepared each time, the EGCG was administered 10 minutes before meals. The repeated slow swallowing of 30 ml of the EGCG solution was essential to ensure sustained contact of the drug on the esophageal walls
Epigallocatechin-3-gallate
Epigallocatechin-3-gallate is administered in a solution with a concentration of 4400 umol/L
Interventions
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Epigallocatechin-3-gallate
Epigallocatechin-3-gallate is administered in a solution with a concentration of 4400 umol/L
Eligibility Criteria
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Inclusion Criteria
* ≥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
* 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
18 Years
ALL
No
Sponsors
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Shandong Cancer Hospital and Institute
OTHER
Responsible Party
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Han Xi Zhao
Deputy Chief Physician
Locations
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Shandong Cancer Hospital
Jinan, Shandong, China
Countries
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Facility Contacts
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Other Identifiers
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GTEEC2024
Identifier Type: -
Identifier Source: org_study_id
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