Spots Global Cancer Trial Database for Maintenance Treatment of Apatinib in Nasopharyngeal Carcinoma

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Trial Identification

Brief Title: Maintenance Treatment of Apatinib in Nasopharyngeal Carcinoma

Official Title: Phase II Trial of Maintenance Apatinib After Second-Line Treatment for Locally Recurrent or Metastatic Nasopharyngeal Carcinoma

Study ID: NCT03130270

Conditions

Nasopharyngeal Carcinoma

Interventions

Apatinib mesylate tablet

Study Description

Brief Summary: The study is to evaluate the efficacy and safety of Apatinib for later treatment of patients(after second-line treatment for locally recurrent or metastatic nasopharyngeal carcinoma), including overall survival (OS), distant metastasis-free survival (DMFS) and locoregional relapse-free survival (LRRFS); the relationship between EBV DNA copy number and survival after radiotherapy or radiochemotherapy; Quality of life score (QoL); evaluation of drug safety.

Detailed Description: In locally advanced nasopharyngeal carcinoma(NPC), although fist-line therapy with radiotherapy and chemotherapy (Cisplatin/Docetaxel/5-Fu) and second-line therapy with chemotherapy has been given, patients still locally recurrence and distant metastasis. There is no standard treatment recommendation for locally recurrent or metastatic NPC who failed to second-line therapy. Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III studies of liver cancer, non small cell lung cancer and other tumors also showed apatinib has less toxicities and better tolerance. However, the clinical application of apatinib in nasopharyngeal carcinoma is still lack of evidence-based medicine. And this trial is designed to investigate the efficacy and safety of apatinib in locally recurrent or metastatic NPC.