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A Phase II Clinical Study of Endostar Combination With Chemotherapy in the Metastatic Nasopharyngeal Carcinoma


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Nasopharyngeal Carcinoma

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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

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