The study is designed to assess the safety and efficacy of S-1 plus cisplatin hyperthermic intraperitoneal chemotherapy in stage Ⅲ patients after D2 gastrectomy
The study is a randomized clinical trial,and subjects wuill be assigned two arms: SP Intravenous Chemotherapy or SP by HIPEC .After 8 cycles treatment,we assess the safety and efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
270
Using cisplatin in HIPEC plus oral S-1
IEC of Insititution for National Drug Clinical Trials,Tangdu Hospital,Fourth Military Medical University
Xi'an, Shaanxi, China
RECRUITINGDFS: Disease-Free Survival
from the date of random to the date of recurrence or death for disease progression.
Time frame: 2 years
OS: Overall Survival
From the date of random to the date of death or to the end of follow-up
Time frame: 5 years
The quality of life
The subjects should finish the quality of life scale by themselves before treament in every cycle.
Time frame: 6 months
Safety as measured by Adverse Events and Serious Adverse events In the process of the total treatment according CTCAE4.0
record and collect subjects' AE and SAE In the process of the total treatment according CTCAE4.0
Time frame: 6 months
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