Status:
RECRUITING
A Phase II Clinical Study of Epigallocatechin-3-gallate in Patients With Esophageal Squamous Cancer
Lead Sponsor:
Shandong Cancer Hospital and Institute
Conditions:
Esophageal Cancer
Dysphagia, Esophageal
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ra...
Eligibility Criteria
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
Key Trial Info
Start Date :
April 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 22 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06398405
Start Date
April 22 2024
End Date
May 22 2026
Last Update
May 3 2024
Active Locations (1)
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1
Shandong Cancer Hospital
Jinan, Shandong, China, 250117