The purpose of this study is to compare the efficacy of S1 plus paclitaxel (intravenous injection \& intraperitoneal injection) plus bevacizumab (intraperitoneal injection) vs. S1 plus oxaliplatin intravenous injection as first-line treatment in gastric or gastroesophageal junctional adenocarcinoma with malignant ascites.
This is a prospective, open-label, multicenter clinical trial, to compare the efficacy of S1 plus paclitaxel (intravenous injection \& intraperitoneal injection) plus bevacizumab (intraperitoneal injection) versus S1 plus oxaliplatin intravenous injection as first-line treatment in gastric or gastroesophageal junctional adenocarcinoma with malignant ascites. A total of 66 patients who are diagnosed with gastric or gastroesophageal junctional adenocarcinoma will be allocated to receive either S1 orally administration plus paclitaxel intravenous injection \& intraperitoneal injection plus bevacizumab intraperitoneal injection, or to receive S1 orally administration plus oxaliplatin intravenous injection. The primary end point is ascites response rate at 6 weeks. The secondary end points include the median overall survival (OS), progression-free survival (PFS), time to treatment failure (TTF), objective response rate (ORR), puncture free survival, volume of drainage, the quality of life (QoL) and safety.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
80-120 mg/day, PO, D1-14, every 21 days
20 mg/m2/day, IP, D1-3; 50 mg/m2, IV, D1; 70 mg/m2, IV, D8; every 21 days
200 mg, IP, D1, every 21 days
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGAscites response rate at 6 weeks
response of ascites at 6 weeks
Time frame: 6 weeks
PFS
Progression-free survival,From 1st drug administration to the date of first progression or date of death (whichever occurs first)
Time frame: 12 months
OS
Overall survival, from enrollment until death from any cause
Time frame: 2 years
ORR
Objective response rate, the proportion of patients with reduction in tumor burden of a predefined amount
Time frame: 12 months
TTF
Time to treatment failure, from 1st drug administration to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death
Time frame: 12 months
Puncture free survival
Puncture free survival time, from the first puncture to secondary puncture
Time frame: 12 months
Volume of drainage
Volume of drainage
Time frame: 12 months
Adverse events
Adverse events
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
130 mg/m2, IV, D1, every 21 days