Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Pharmaceutical Solutions

All Drugs and Chemicals

Antineoplastic Agents

Neuroprotective Agents

Flavonoid

Epigallocatechin gallate

Epigallocatechin

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 more than grade II 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 7 days before anti-tumor treatment.

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 30 ml of the EGCG solution is indispensable to assure the prolonged presence of drug the esophageal walls.

EGCG

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.

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

the toxicities will be reported by describing Adverse Events (AE) per CTCAE v5.0, by dose level, and type and grade of toxicity

Response rate of esophageal stenosis was determined by X-ray barium meal examination and/or contrast-enhanced CT

choking and pain when swallowing was assessed by Stooler's dysphagia score and NRS

This will be determined by prealbumin and albumin values

Shandong Cancer Hospital and Institute

Principal Investigator

Diseases and Abnormalities at or Before Birth

Symptoms and General Pathology

Musculoskeletal Diseases

Nervous System Diseases

Hirschsprung Disease

Gastroparesis

Muscle Spasticity

Diverticulum

Diverticular Diseases

Zenker Diverticulum

Neurologic Manifestations

Stomach Diseases

Paralysis

Congenital Abnormalities

Digestive System Abnormalities

Megacolon

Colonic Diseases

Intestinal Diseases

Gastroenteritis

Pathological Conditions, Anatomical

Diverticulum, Esophageal

To test the idea that submucosal endoscopy is effective and safe for endoscopic myotomy, endoscopic submucosal dissection, and access for tissue acquisition and resection. Submucosal endoscopy is a recent innovative addition to gastrointestinal endoscopy. This involves endoscopic maneuvers in the gut wall, by dissection of the submucosal layer of GI tract, thereby allowing endoscopic myotomy (incision of the muscle), endoscopic access for tissue acquisition and therapy, and resection of precancerous and cancerous gastrointestinal tissue. This approach has been a dramatic game-changer for minimally invasive management of various gastrointestinal conditions such as Zenker's diverticulum, Achalasia, Spastic Esophageal Disorders, Gastroparesis, esophageal obstruction, Hirschsprung's Disease, and Gastrointestinal neoplasia.

The aim of the proposed study is to prospectively assess technical success, clinical success, and adverse events after submucosal endoscopy. Technical success will be defined as ability to successfully complete the submucosal endoscopic procedure. Clinical success will be defined as symptom relief and objective evaluation which will be assessed with radiologic imaging, repeat endoscopy, gastrointestinal motility studies, and pathology results routinely performed post-procedure for clinical care, as indicated. Adverse events will be recorded per published ASGE criteria.

A database/ registry of patients undergoing submucosal endoscopic procedures will be created to demonstrate this.

Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy

Improvement in symptoms and objectively assessed by radiologic imaging, repeat endoscopy, gastrointestinal motility studies, and pathology.

Submucosal endoscopy technique and device used

University of Colorado, Denver

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Epigallocatechin-3-gallate (EGCG) for Supportive and Symptomatic Management in Patients With Esophageal Cancer	NCT05039983	Esophageal Obst...	EGCG	18 Years -	Shandong Cancer Hospital and Institute
Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy	NCT03626350	Gastrointestina... Hirschsprung's ... Esophageal Obst... Gastroparesis Spastic Esophag... Zenker's Divert...		18 Years - 89 Years	University of Colorado, Denver
Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy	NCT03626350	Gastrointestina... Hirschsprung's ... Esophageal Obst... Gastroparesis Spastic Esophag... Zenker's Divert...		18 Years - 89 Years	University of Colorado, Denver

Spots Global Cancer Trial Database for esophageal obstruction