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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
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.
Shan Dong cancer hospital and institute
Jinan, Shandong, China
Dose limiting toxicity (DLT)
the toxicities will be reported by describing Adverse Events (AE) per CTCAE v5.0, by dose level, and type and grade of toxicity
Time frame: baseline and up to 7 days post-treatment
Maximum tolerated dose (MTD)
the toxicities will be reported by describing Adverse Events (AE) per CTCAE v5.0, by dose level, and type and grade of toxicity
Time frame: baseline and up to 7 days post-treatment
Recommended phase 2 dose (RP2D)
the toxicities will be reported by describing Adverse Events (AE) per CTCAE v5.0, by dose level, and type and grade of toxicity
Time frame: baseline and up to 7 days post-treatment
Imaging objective response rate
Response rate of esophageal stenosis was determined by X-ray barium meal examination and/or contrast-enhanced CT
Time frame: Change from Baseline esophageal stenosis size at 7 days
Symptom objective response rate
choking and pain when swallowing was assessed by Stooler's dysphagia score and NRS
Time frame: baseline and up to 7 days post-treatment
change in blood biochemical indicators
This will be determined by prealbumin and albumin values
Time frame: baseline and up to 8 days post-treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.