First Line Chemotherapy for Advanced Cancer
Conditions
Gastric Cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: albumin-bounded paclitaxel Type: Drug
Name: S-1 Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to determine whether albumine-bounded paclitaxel plus S-1 are effective in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma.
Detailed Description
This phase II study was designed to evaluate the efficacy and safety of albumin-bounded paclitaxel combined with S-1 as first-line chemotherapy for inoperable and /or metastatic gastric or gastroesophageal junction cancer.Primary endpoint was overall response rate.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Inoperable locally advanced, recurrent, and/or metastatic adenocarcinoma of the stomach or gastro-esophageal junction

- Adult patients >=18 years of age

- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2;

- At least have one measurable disease(according to RECIST)

- Adequate bone marrow,renal and liver function

Exclusion Criteria:

- Previous chemotherapy for advanced/metastatic disease

- Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome
Location
Department of Medical Oncology,Cancer Hostpital and Institute,CAMS
Beijing, China
Status: Recruiting
Contact: Yan Song, MD - 86-10-87788145 - song-yan@hotmail.com
Start Date
September 2013
Completion Date
February 2016
Sponsors
Chinese Academy of Medical Sciences
Source
Chinese Academy of Medical Sciences
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page