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

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)

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60 participants in 1 patient group

nedaplatin combined with gemcitabine

Experimental group

Treatment:

Drug: nedaplatin and gemcitabine