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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Patients with locally recurrent or metastatic nasopharyngeal carcinoma (NPC) after second-line treatment are assigned to receive apatinib mesylate tablet. A treatment cycle was defined as 28 days (4 weeks). The starting dose was 500 mg, orally, qd; tolerance assessment for a cycle, patients with poorly tolerance were treated with low dose (500 mg, qd), and patients with well tolerance were treated with high dose (750 mg, qd). All patients continuous treatment until progression disease or non-tolerated toxicity. Note: good tolerance was defined that no grade 3/4 hematology or/and non hematologic side effects occurred within 4 weeks after initiation treatment; poor tolerance was defined that grade 3/4 hematology or/and non hematologic side effects appeared within 4 weeks after initiation treatment.
Guilin Medical University
Guilin, Guangxi, China
Nanxishan hospital
Guilin, Guangxi, China
National Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China
Objective Response Rate (ORR) after Second-Line Treatment for Locally Recurrent or Metastatic Nasopharyngeal Carcinoma
To evaluate ORR every 6-8 weeks after initiation of apatinib.
Time frame: up to 24 months
Disease-free survival (DFS)
The time from the first day of therapy to locoregional relapse, distant relapse again or tumor-related death.
Time frame: up to 24 months
Overall survival (OS)
The time from the first day of therapy to death or last follow-up.
Time frame: up to 24 months
Toxicity evaluation
Related toxicities were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Time frame: up to 24 months
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