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Phase 2
18 Years
75 Years
Open (Enrolling)
Gastric Cancer

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Trial Information

Inclusion Criteria:

- Signed informed consent form

- Performance Status-Eastern Cooperative Oncology Group (ECOG) 0-1

- Histologically or cytologically confirmed gastric cancer

- Advanced or recurrent, metastatic disease

- At least have one measurable disease(according to RECIST, Response Evaluation
Criteria in Solid Tumors )

- Life expectancy of at least 3 months

- Target target lesion has not received radiotherapy or non target lesion radiation at
least 4 weeks

- Haematopoietic and Hepatic status:

Absolute neutrophil count >1.5x109/L,Platelet count > 100 x 109/L,Hemoglobin at least 9
g/dl,Bilirubin ≤ 1.5 x upper limit of normal (ULN),AST and ALT ≤ 2.5 times ULN(no liver
metastasis), ≤5 times ULN(with liver metastasis)

- Cardiovascular: Baseline LVEF 50% measured by echocardiography

Exclusion Criteria:

- Symptomatic brain metastasis

- Active or uncontrolled infection

- Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities
greater than grade 2; peripheral neuropathy of grade 2 or greater Symptomatic brain

- Known history of uncontrolled or symptomatic angina, clinically significant
arrhythmias, congestive heart failure, uncontrolled hypertension (≥ 180/110),
unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen

- History of other malignancy

- Pregnant or lactating women

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival(PFS)

Outcome Time Frame:

1 years

Safety Issue:


Principal Investigator

Wei Liu

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hebei Tumor Hospital


China: Food and Drug Administration

Study ID:




Start Date:

October 2012

Completion Date:

December 2014

Related Keywords:

  • Gastric Cancer
  • Stomach Neoplasms