First Line Chemotherapy for Advanced Cancer
Gastric Cancer
Study Type
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: albumin-bounded paclitaxel Type: Drug
Name: S-1 Type: Drug
Overall Status
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
Department of Medical Oncology,Cancer Hostpital and Institute,CAMS
Beijing, China
Status: Recruiting
Contact: Yan Song, MD - 86-10-87788145 -
Start Date
September 2013
Completion Date
February 2016
Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
Record processing date processed this data on July 28, 2015 page