NCT03990103

S1+ Paclitaxel (IV&IP) + Bevacizumab (IP) Versus S1+Oxaliplatin as First-line Treatment in Gastric Cancer With Malignant Ascites

S1 Plus Paclitaxel (IV&IP) Plus Bevacizumab (IP) Versus S1 Plus Oxaliplatin(IV) as First-line Treatment in Gastric or Gastroesophageal Junctional Adenocarcinoma With Malignant Ascites: An Open-label, Multicenter Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: China Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Metastatic Gastric Adenocarcinoma

Interventions

Type	Name	Description
DRUG	S1	80-120 mg/day, PO, D1-14, every 21 days
DRUG	Paclitaxel	20 mg/m2/day, IP, D1-3; 50 mg/m2, IV, D1; 70 mg/m2, IV, D8; every 21 days
DRUG	Bevacizumab	200 mg, IP, D1, every 21 days
DRUG	Oxaliplatin	130 mg/m2, IV, D1, every 21 days

Timeline

• Start date: 2017-11-01
• Primary completion: 2021-04-30
• Completion: 2022-04-30
• First posted: 2019-06-18
• Last updated: 2019-06-19

Locations

1 site across 1 country: China