Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment in Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

• Tumor response rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• Disease control rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• Overall survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]
• adverse evens [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]

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.

• Drug: Paclitaxel
  80mg/m2 infusion,d1,d8 every 3 weeks
• Drug: capecitabine
  Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks
• Drug: cisplatin
  80mg/m2, day 1 of every 3 weeks

• Active Comparator: Cisplatin plus capecitabine
  Interventions:

  • Drug: capecitabine
  • Drug: cisplatin
• Experimental: Paclitaxel plus Capecitabine
  Interventions:

  • Drug: Paclitaxel
  • Drug: capecitabine

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