This study will enroll patients with non-metastatic nasopharyngeal carcinoma (NPC) that have residual Epstein-Barr virus (EBV) DNA after curative radiotherapy or chemoradiotherapy. The purpose is to evaluate the survival in these patients treated with apatinib (YN968D1), an inhibitor of vascular endothelial growth factor receptor (phase IIa) and to compare the survival in these patients treated with apatinib versus placebo (phase IIb).
This study has two parts. In the single arm phase IIa part, we will enroll 25 patients that have residual Epstein-Barr virus (EBV) DNA after curative radiotherapy or chemoradiotherapy. All patients will receive apatinib. The purpose is to evaluate the disease free-survival (DFS) in these patients treated with apatinib. In the phase IIb part, patients will be randomized to apatinib or placebo in a ratio of 1:1. The estimated sample size is 78 in phase IIb. However, the final sample size in phase IIb will be determined based on results of the phase IIa part.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
25
Patients will take oral apatinib. The initial dose is 500 mg once daily. 28 days as one cycle. After 1 cycle, the dose will be escalated to 750 mg once daily in patients with good tolerance. Dose interruption or reduction is permitted in case of adverse events per protocol.
Patients will take oral placebo. The initial dose is 500 mg once daily. 28 days as one cycle. After 1 cycle, the dose will be escalated to 750 mg once daily in patients with good tolerance. Dose interruption or reduction is permitted in case of adverse events per protocol.
Affiliated Foshan Hospital of Sun Yat-sen University
Foshan, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Disease-free survival
Time frame: 3 years
overall survival
Time frame: 5 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 2 years
Changes in quality of life (QOL) as assessed by EORTC QLQ-C30
Time frame: 2 years
Distance Metastasis Free Survival
Time frame: 3 years
locoregional relapse free survival
Time frame: 3 years
Correlation of plasma EBV DNA load with the effect of apatinib on survival
Time frame: 3 years
Correlation of pretreatment serum VEGF level with the effect of apatinib on survival
Time frame: 3 years
Correlation of pretreatment serum VEGFR-2 level with the effect of apatinib on survival
Time frame: 3 years
Correlation of adverse event (hypertension) with the effect of apatinib on survival
Time frame: 3 years
Correlation of adverse event (hand-foot syndrome) with the effect of apatinib on survival
Time frame: 3 years
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Correlation of the change from baseline in serum VEGF level at 4 weeks with the effect of apatinib on survival
Time frame: 3 years
Correlation of the change from baseline in serum VEGFR-2 level at 4 weeks with the effect of apatinib on survival
Time frame: 3 years