Nasopharyngeal Carcinoma
Conditions
Keywords
Recombinant human endostatin, nasopharyngeal carcinoma, chemotherapy
Brief summary
The investigators designed this study to evaluate the efficiency and the acute toxicities of recombinant human endostatin (endostar) combined with chemotherapy in the metastatic nasopharyngeal carcinoma (NPC).
Detailed description
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).
Interventions
DRUGendostatin
Gemcitabine 1.0g/m2 d1,8 cisplatin 80mg/m2 endostatin 15mg/d 14days/cycle \*4cycles
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progress free survival(PFS) | 1 year and 2years | PFS means assignament to the date of any local or distant progress of the disease useing Kaplan-Meier caculate the progress free survival rates |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival(OS) | baseline to date of death from any cause | the overall survival denote to assignment to date of death from any cause. Using Kaplan-Meier to caculate the 1-year ,2-year,3-year overall survival rate |
| Adverse events | participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 1 year | observe and record the toxicity profile(incluing but not limit to mocositis,liver and kidney function,et al.)according NCI-CTCAE(3rd edtion) during the chemotherapy,Targeted therapy and follow-up |
Countries
China
Outcome results
None listed