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ADjuVant Apatinib in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy (ADVANCE)

2021年12月25日 更新者:Jun Ma, MD、Sun Yat-sen University

ADjuVant Apatinib in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy With or Without Chemotherapy

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).

研究概览

地位

终止

条件

详细说明

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.

研究类型

介入性

注册 (实际的)

25

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Guangdong
      • Foshan、Guangdong、中国、528000
        • Affiliated Foshan Hospital of Sun Yat-sen University
      • Guangzhou、Guangdong、中国、510060
        • Sun Yat-sen University Cancer Center
    • Guangxi
      • Guilin、Guangxi、中国、541000
        • Affiliated Hospital of Guilin Medical University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Biopsy proven nasopharyngeal carcinoma, with detectable pretreatment plasma EBV DNA
  2. Have detectable plasma EBV DNA at the end of (+/- 1 week) curative radiotherapy or chemoradiotherapy (radiation dose > 66Gy), determined by the central lab
  3. No clinical evidence of persistent loco-regional disease
  4. No evidence of distant metastasis, based upon skeletal scintigraphy, chest X-ray examination, and liver ultrasound or other appropriate workup (e.g., CT, MRI or positron emission tomography (PET)/CT]) within 21 days prior to registration
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  6. Anticipated survival >= 3 months
  7. Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
  8. Platelets > 80,000 cells/mm^3
  9. Hemoglobin >= 8.0 g/dl (no transfusion within the last 14 days)
  10. Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
  11. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 x institutional ULN
  12. Creatinine clearance (CC) >= 50 ml/min estimated by Cockcroft-Gault formula

Exclusion Criteria:

  1. Patients with stage III-IV disease (American Joint Committee On Cancer/Union for International Cancer Control 7th) and no contraindication to chemotherapy that didn't receive platinum based concurrent chemotherapy during radiation
  2. Patients with tumor possibly invaded main vessels (e.g. encasement of the internal jugular artery/vein) at diagnosis; or tumor that, in the judgment of the investigator, likely to invade main vessels and cause life-threatening hemorrhage events during study
  3. History of serious hemorrhage events or grade 3 or higher hemorrhage within 4 weeks prior to registration
  4. Hypertension that couldn't be well controlled with single medication; unstable angina; angina diagnosed within the last 3 months; myocardial infarction within the last 6 months; cardiac arrhythmia that need long-term medication; grade 2 or higher cardiac dysfunction (NYHA)
  5. Proteinuria
  6. Coagulation dysfunction or predisposition to hemorrhage; on treatment of anticoagulation medication or vitamin K antagonist; low dose warfarin (1mg po qd) or aspirin (less than 100mg daily) were permitted as long as the international normalized ratio (INR) = < 1.5
  7. Thrombosis within the last 1 year, except cured vein thrombosis related to vein indwelling catheter
  8. Unhealed bone fracture or chronic unhealed wound
  9. Illness that would interfere with oral medication, including dysphagia, chronic diarrhea, or ileus
  10. Pregnant or lactating women
  11. Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception during and within 6 months after study
  12. Current drug abuse or mentally disabled
  13. History of congenital or acquired immune deficiency disease or organ transplantation
  14. Major medical illness, which in the investigator's opinion would endanger the patients or interfere with the completion of therapy and follow up

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的:Apatinib
In the phase IIb part of this trial, patients in this arm will take oral apatinib until disease progression, intolerable toxicity, death or to a maximum of 2 years.
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.
其他名称:
  • YN968D1
安慰剂比较:Placebo
In the phase IIb part of this trial, patients in this arm will take oral placebo until disease progression, intolerable toxicity, death or to a maximum of 2 years.
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.
其他名称:
  • 安慰剂片剂

研究衡量的是什么?

主要结果指标

结果测量
大体时间
无病生存
大体时间:3年
3年

次要结果测量

结果测量
大体时间
总生存期
大体时间:5年
5年
根据 CTCAE v4.0 评估的发生治疗相关不良事件的参与者人数
大体时间:2年
2年
Changes in quality of life (QOL) as assessed by EORTC QLQ-C30
大体时间:2 years
2 years
Distance Metastasis Free Survival
大体时间:3 years
3 years
locoregional relapse free survival
大体时间:3 years
3 years
Correlation of plasma EBV DNA load with the effect of apatinib on survival
大体时间:3 years
3 years
Correlation of pretreatment serum VEGF level with the effect of apatinib on survival
大体时间:3 years
3 years
Correlation of pretreatment serum VEGFR-2 level with the effect of apatinib on survival
大体时间:3 years
3 years
Correlation of adverse event (hypertension) with the effect of apatinib on survival
大体时间:3 years
3 years
Correlation of adverse event (hand-foot syndrome) with the effect of apatinib on survival
大体时间:3 years
3 years
Correlation of the change from baseline in serum VEGF level at 4 weeks with the effect of apatinib on survival
大体时间:3 years
3 years
Correlation of the change from baseline in serum VEGFR-2 level at 4 weeks with the effect of apatinib on survival
大体时间:3 years
3 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年10月1日

初级完成 (实际的)

2018年11月29日

研究完成 (实际的)

2020年8月27日

研究注册日期

首次提交

2016年8月1日

首先提交符合 QC 标准的

2016年8月17日

首次发布 (估计)

2016年8月22日

研究记录更新

最后更新发布 (实际的)

2022年1月11日

上次提交的符合 QC 标准的更新

2021年12月25日

最后验证

2021年12月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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