A Study of Intraperitoneal Paclitaxel in Combination With SOX Compared With SOX Alone in Gastric Cancer With Malignant Ascites

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to compare the efficacy of intraperitoneal paclitaxel in combination with SOX, with SOX alone in the first-line treatment of gastric cancer with malignant ascites

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Albumin-Bound Paclitaxel; Oxaliplatin; Paclitaxel; Tegafur

Criteria

Inclusion Criteria:

• had a histologically proven adenocarcinoma of the gastroesophageal junction, or stomach that was locally advanced (inoperable) or metastatic

• malignant ascites(over pelvic cavity in CT scan and confirmed by cytology)

• an Eastern Cooperative Oncology Group performance status of 0 to 2

• adequate renal, hepatic, and hematologic function

Exclusion Criteria:

• previous chemotherapy or radiotherapy (unless in the adjuvant setting)

• uncontrolled cardiac disease, or other clinically significant, uncontrolled

• coexisting illness or previous or concurrent cancer

• HER2 positive and willing to use trastuzumab