Trial Information
A Phase II Clinical Study of Endostar Combination With Chemotherapy in the Metastatic Nasopharyngeal Carcinoma
To evaluate the progression free survival (PFS), overall survival (OS), Acute adverse
reaction of recombinant human endostatin (endostar) combined with chemotherapy to the
metastatic nasopharyngeal carcinoma (NPC).
Inclusion Criteria:
- Diagnosed metastatic NPC patient who have received radiotherapy or chemoradiotherapy
with an at least 6 months interval
- Have measurable lesions
- No dysfunction of the major organs
- Can understand this study and give a signed informed consent certificates
- without a history of allergic reaction to the biological agents
Exclusion Criteria:
- Pregnant or lactating women; Women of child-bearing age without contraception
- with a Serious infection or dysfunction of the major organs
- have taken other antitumor drugs during the period of 30 days ahead of this clinical
trial
- allergic to the Escherichia coli preparations
- Cann't understand this study and give a signed informed consent certificates
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
progress free survival(PFS)
Outcome Description:
PFS means assignament to the date of any local or distant progress of the disease useing Kaplan-Meier caculate the progress free survival rates
Outcome Time Frame:
1 year and 2years
Safety Issue:
No
Principal Investigator
Bin Li
Investigator Role:
Principal Investigator
Investigator Affiliation:
Zhejiang Cancer Hospital
Authority:
China: Food and Drug Administration
Study ID:
ZhejaingCH-npc-02
NCT ID:
NCT01612286
Start Date:
May 2012
Completion Date:
May 2014
Related Keywords:
- Nasopharyngeal Carcinoma
- Recombinant human endostatin
- nasopharyngeal carcinoma
- chemotherapy
- Carcinoma
- Nasopharyngeal Neoplasms