Clinical trial · Interventional
A Phase II Clinical Study of Epigallocatechin-3-gallate in Patients With Esophageal Squamous Cancer
Efficacy and Safety of Epigallocatechin-3-gallate, an Important Polyphenolic That Originates From Tea, in Patients With Esophageal Squamous Cancer: A Phase II Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators conduct this phase II study to evaluate safety and effectiveness of EGCG in patients with dysphagia. Swallowing-related dysphagia and pain scores were recorded using the numerical rating scale (NRS) daily . Barium meal radiography was utilized to measure the luminal size and the length of the lesion area both before and after a week of EGCG treatment. The scales are translated into Chinese and guides in Chinese are developed instructing how to use the scales and perform the assessments.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dysphagia, Esophageal | — | UNRESOLVED | — |
| Epigallocatechin Gallate | — | UNRESOLVED | — |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epigallocatechin-3-gallate | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EGCG ARM
- description
- 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
- interventionNames
- Other: Epigallocatechin-3-gallate
Primary outcomes (3)
- measure
- Choking symptom objective response rate
- timeFrame
- baseline and up to 7 days post-treatment
- description
- Choking when swallowing was assessed by Stooler's dysphagia score (0-4, with 0 being none and 4 being completely unable to feed orally)
- measure
- Pain symptom objective response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available