HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Nasopharyngeal Carcinoma

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Brief Title

HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Nasopharyngeal Carcinoma

Official Title

HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Nasopharyngeal Carcinoma: Clinical Trial

Brief Summary

      The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional
      therapy using digital subtraction angiography（DSA） for nasopharyngeal carcinoma.

Detailed Description

      By enrolling patients with nasopharyngeal carcinoma adapted to enrolled criteria, this study
      will document for the first time the safety and the short and long term efficacy of
      HepaSphere interventional therapy using digital subtraction angiography （DSA） for
      nasopharyngeal carcinoma.

Study Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

Number of participants with Adverse events

Secondary Outcome

 Percentage of lesions interventional therapy that show no sign of recurrence 12 months after

Condition

Nasopharyngeal Carcinoma

Intervention

interventional therapy

Study Arms / Comparison Groups

 HepaSphere
Description:  nasopharyngeal carcinoma patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

60

Start Date

May 2015

Completion Date

June 2016

Primary Completion Date

June 2016

Eligibility Criteria

        Inclusion Criteria:

          1. Age:18-80

          2. Karnofsky performance status >60

          3. Diagnosis of nasopharyngeal carcinoma based on histology or the current accepted
             radiological measures.

          4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ

          5. Will receive interventional therapy

          6. Life expectancy: Greater than 3 months

          7. Patients' routine blood test, liver function and kidney function have no obvious
             abnormalities

          8. Ability to understand the study protocol and a willingness to sign a written informed
             consent document

        Exclusion Criteria:

          1. Patients with other primary tumor except nasopharyngeal carcinoma

          2. History of coagulation disorders or anemia

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Lizhi Niu, PhD, ,

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT02523430

Organization ID

NPC HepaSphere

Responsible Party

Sponsor

Study Sponsor

Fuda Cancer Hospital, Guangzhou

Study Sponsor

Lizhi Niu, PhD, Study Chair, Fuda Cancer Hospital

Verification Date

October 2015