Esophageal Obstruction
Conditions
Keywords
EGCG, Esophageal obstruction, Supportive and Symptomatic Management
Brief summary
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.
Interventions
OTHEREGCG
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.
Sponsors
Shandong Cancer Hospital and Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose limiting toxicity (DLT) | baseline and up to 7 days post-treatment | the toxicities will be reported by describing Adverse Events (AE) per CTCAE v5.0, by dose level, and type and grade of toxicity |
| Maximum tolerated dose (MTD) | baseline and up to 7 days post-treatment | the toxicities will be reported by describing Adverse Events (AE) per CTCAE v5.0, by dose level, and type and grade of toxicity |
| Recommended phase 2 dose (RP2D) | baseline and up to 7 days post-treatment | the toxicities will be reported by describing Adverse Events (AE) per CTCAE v5.0, by dose level, and type and grade of toxicity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Imaging objective response rate | Change from Baseline esophageal stenosis size at 7 days | Response rate of esophageal stenosis was determined by X-ray barium meal examination and/or contrast-enhanced CT |
| Symptom objective response rate | baseline and up to 7 days post-treatment | choking and pain when swallowing was assessed by Stooler's dysphagia score and NRS |
| change in blood biochemical indicators | baseline and up to 8 days post-treatment | This will be determined by prealbumin and albumin values |
Countries
China
Outcome results
None listed