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Nedaplatin Combined With Gemcitabine in the Treatment of Recurrent and/or Metastatic Nasopharyngeal Carcinoma : a Single Arm and Phase Ⅱ Clinical Trail

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Sun Yat-sen University

Status and phase

Terminated
Phase 2

Conditions

Recurrent and Metastatic Nasopharyngeal Carcinoma

Treatments

Drug: nedaplatin and gemcitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT02789189
B2015-073-01

Details and patient eligibility

About

The purpose of this single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of nedaplatin combined with gemcitabine in the treatment of recurrent and metastatic nasopharyngeal carcinoma

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • biopsy proved nasopharyngeal carcinoma; stage IVc according to Union for International Cancer Control (UICC) edition VII,or recurrent disease after chemotherapy and/or radiotherapy; 18 years or older; without other malignancy; proper functioning of the major organs.

Exclusion criteria

  • allergic to nedaplatin and/or gemcitabine; female within gestation period or lactation; patients received drug of other clinical trail within 3 months.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

nedaplatin combined with gemcitabine
Experimental group
Treatment:
Drug: nedaplatin and gemcitabine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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