NCT05039983

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

Completed Phase 1 Last updated 3 April 2024

What this trial tests

Phase 1 trial testing EGCG in Esophageal Obstruction in 18 participants. Completed in 2 January 2024.

Timeline

20 August 2021

Primary endpoint
27 December 2023

2 January 2024

Quick facts

Lead sponsor	Shandong Cancer Hospital and Institute
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	20 August 2021
Primary completion	27 December 2023
Estimated completion	2 January 2024
Sites	1 location across China

Drugs / interventions tested

• EGCG — full drug profile →

Conditions studied

• Esophageal Obstruction — all drugs for Esophageal Obstruction →

Sponsor

Shandong Cancer Hospital and Institute

Who can join

18 and older, any sex, with Esophageal Obstruction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Epigallocatechin-3-Gallate Therapeutic Potential in Cancer: Mechanism of Action and Clinical Implications.
   Kciuk M, Alam M, Ali N, Rashid S, et al · · 2023 · cited 72× · PMID 37446908 · DOI 10.3390/molecules28135246
2. A Review: PI3K/AKT/mTOR Signaling Pathway and Its Regulated Eukaryotic Translation Initiation Factors May Be a Potential Therapeutic Target in Esophageal Squamous Cell Carcinoma.
   Huang R, Dai Q, Yang R, Duan Y, et al · · 2022 · cited 31× · PMID 35574327 · DOI 10.3389/fonc.2022.817916
3. Role of Plant-Derived Active Constituents in Cancer Treatment and Their Mechanisms of Action.
   Khan AW, Farooq M, Haseeb M, Choi S. · · 2022 · cited 31× · PMID 35456005 · DOI 10.3390/cells11081326
4. Role of PD-1/PD-L1 signaling axis in oncogenesis and its targeting by bioactive natural compounds for cancer immunotherapy.
   Godiyal Y, Maheshwari D, Taniguchi H, Zinzuwadia SS, et al · · 2024 · cited 21× · PMID 39690423 · DOI 10.1186/s40779-024-00586-9
5. Destroying the Shield of Cancer Stem Cells: Natural Compounds as Promising Players in Cancer Therapy.
   Lo Iacono M, Gaggianesi M, Bianca P, Brancato OR, et al · · 2022 · cited 13× · PMID 36498571 · DOI 10.3390/jcm11236996
6. Natural anti-cancer products: insights from herbal medicine.
   Cui D, Zhang C, Zhang L, Zheng J, et al · · 2025 · cited 9× · PMID 40490812 · DOI 10.1186/s13020-025-01124-y
7. Plant-Derived Antioxidants as Modulators of Redox Signaling and Epigenetic Reprogramming in Cancer.
   Truong TT, Singh AA, Tak S, Na S, et al · · 2025 · cited 2× · PMID 41439968 · DOI 10.3390/cells14241948
8. Epigenetic drugs in cancer therapy: mechanisms, immune modulation, and therapeutic applications.
   Ma C, Cheng J, Gu J, Wang Q. · · 2025 · cited 2× · PMID 41335282 · DOI 10.1186/s43556-025-00373-5