Advanced Gastric Cancer
Conditions
Brief summary
The purpose of this study is to investigate whether Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment as 1st line treatment in he advanced gastric cancer is effective and safe.
Interventions
DRUGPaclitaxel
80mg/m2 infusion,d1,d8 every 3 weeks
DRUGcapecitabine
Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks
DRUGcisplatin
80mg/m2, day 1 of every 3 weeks
Sponsors
Roche Pharma AG
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Having signed informed consent * Age≥ 18 years old * Histologically confirmed gastric adenocarcinoma * Unresectable recurrent or metastatic disease * Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months * Previous chemotherapy with capecitabine or cisplatin, if applicable, more than 12 months. * Measurable disease according to the RECIST criteria * Karnofsky performance status ≥60 * Life expectancy of ≥2 month * No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks * ALT and AST\<2.5 times ULN (≤5 times ULN in patients with liver metastases) * Serum albumin level ≥3.0g/dL * Serum AKP \< 2.5 times ULN * Serum creatinine \<ULN, and CCr \< 60ml/min * Bilirubin level \< 1.5 ULN * WBC\>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl
Exclusion criteria
* Brain metastasis (known or suspected) * Previous systemic therapy for metastatic gastric cancer * Inability to take oral medication * Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy * Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry * Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on. * Allergic constitution or allergic history to protium biologic product or any investigating agents. * Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension. * Pregnancy or lactation period * Any investigational agent within the past 28 days * Other previous malignancy within 5 year, except non-melanoma skin cancer * Previous adjuvant therapy with capecitabine+platinum, * Pre-existing neuropathy\>grade 1 * Legal incapacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | 3 year |
Secondary
| Measure | Time frame |
|---|---|
| Tumor response rate | 1 year |
| Disease control rate | 1 year |
| Overall survival | 5 year |
| adverse evens | 5 year |
Countries
China
Contacts
Primary ContactZhihao Lu, MD
Backup ContactFu Chen, Bachelor
Outcome results
None listed