Gastric Cancer
Conditions
Brief 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.
Interventions
DRUGalbumin-bounded paclitaxel
200mg iv d1, repeat every 2 weeks,until disease progression,or up to 9 cycles
DRUGS-1
40mg/m2 po, bid,d1-10,repeated every 2 weeks until disease progression
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival | 1 year |
| overall survival | 1 year |
| number of adverse event | 1 year |
Countries
China
Outcome results
None listed