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A Phase II Study of Endostar (Recombinant Human Endostatin ®) With Cisplatin and Capecitabine (Xeloda) as 1st Line Treatment in the Advanced Gastric Cancer

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

Thank you

Trial Information

A Phase II Study of Endostar (Recombinant Human Endostatin ®) With Cisplatin and Capecitabine (Xeloda) as 1st Line Treatment in the Advanced Gastric Cancer

Endostar, a recombinant human endostatin, has shown its antitumor ability in combination in
NSCLC and breast cancer. But to gastric cancer, few clinical data has been reported.
However, bevacizumab, an angiogenesis inhibitor was shown effective in combination with
chemotherapy in advanced gastric cancer in some phase II study. So in this study, we want
to explore whether endostar is also effective and safe in advanced gastric cancer. Response
predictive factor is expected to be identified.

Inclusion Criteria:

- Having signed informed consent

- Age 18 to 70 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:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

3 year

Safety Issue:


Principal Investigator

lin shen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peking University, School of oncology, Department of GI oncology


China: Food and Drug Administration

Study ID:




Start Date:

November 2008

Completion Date:

December 2010

Related Keywords:

  • Advanced Gastric Cancer
  • Stomach Neoplasms