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18 Years
Open (Enrolling)
Gastric Cancer

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Trial Information

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

- 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
- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

circulating tumor cells in blood

Outcome Time Frame:

every 6 weeks

Safety Issue:



China: Food and Drug Administration

Study ID:




Start Date:

June 2012

Completion Date:

December 2014

Related Keywords:

  • Gastric Cancer
  • no-prior chemotherapy
  • Stomach Neoplasms
  • Neoplastic Cells, Circulating