Study of Endostar With Cisplatin and Capecitabine as 1st Line Treatment in the Advanced Gastric Cancer

This study has been completed.
Xiansheng Pharmaceutical Company
Information provided by (Responsible Party):
Shen Lin, Peking University Identifier:
First received: February 11, 2009
Last updated: May 17, 2015
Last verified: May 2015

February 11, 2009
May 17, 2015
November 2008
April 2010   (final data collection date for primary outcome measure)
Progression free survival [ Time Frame: 3 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00842491 on Archive Site
  • 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 alteration of relative regional blood volume of the tumor [ Time Frame: 3weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
Study of Endostar With Cisplatin and Capecitabine as 1st Line Treatment in the Advanced Gastric Cancer
A Phase II Study of Endostar (Recombinant Human Endostatin ®) With Cisplatin and Capecitabine (Xeloda) as 1st Line Treatment in the Advanced Gastric Cancer

The purpose of this study is to investigate whether endostar (recombinant human endostatin)with cisplatin and capecitabine (Xeloda) as 1st line treatment in the advanced gastric cancer is effective and safe.

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.

Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Gastric Cancer
  • Drug: endostar, cisplatin, capecitabine

    Product 1: endostar

    Dosing schedule: 15mg daily dose, d1-14

    Mode of administration: intravenously

  • Drug: capecitabine

    Product 2: capecitabine

    Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks

    Mode of administration: orally

  • Drug: cisplatin

    Product 3: cisplatin

    Dosing schedule: 80mg/m2, day 1 of every 3 weeks

    Mode of administration: intravenously

Experimental: endostar+chemotherapy
  • Drug: endostar, cisplatin, capecitabine
  • Drug: capecitabine
  • Drug: cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2010
April 2010   (final data collection date for primary outcome measure)

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 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
18 Years to 75 Years
Contact information is only displayed when the study is recruiting subjects
Shen Lin, Peking University
Peking University
Xiansheng Pharmaceutical Company
Principal Investigator: lin shen, MD Peking University, School of oncology, Department of GI oncology
Peking University
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP