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临床试验/NCT03384511
NCT03384511已完成4 期

Whether 18F-ALF-NOTA-PRGD2 PET/CT Scan Can Predict the Efficacy and Adverse Events of Apatinib in Patients With Malignancies.

Shandong Cancer Hospital and Institute0 个研究点目标入组 38 人开始时间: 2016年9月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
38
主要终点
Tumor response defined by RECIST criteria

研究概览

简要总结

This is an open-label, single arm study to explore whether 18F-ALF-NOTA-PRGD2 PET/CT scan can predict the efficacy and adverse events of apatinib in patients with malignancies.

Integrin αvβ3 has been shown to play an important role in angiogenesis and up-regulated obviously in various types of tumor cells and activated endothelial cells. The arginine-glycine-aspartic acid (RGD) tripeptide sequence can bind to integrin αvβ3 with high affinity and specificity. The 18F-ALF-NOTA-PRGD2 will highly combine with αvβ3, and thus will monitor the antiangiogenic status.In the current study, investigators propose to evaluate the feasibility of 18F-RGD PET/CT in monitoring efficacy and adverse events of apatinib in malignancies.

详细描述

This is an open-label, single arm study to explore whether 18F-ALF-NOTA-PRGD2 positron emission tomography/computed tomography (18F-RGD PET/CT) scan can predict the efficacy and adverse events of apatinib in patients with malignancies.

Angiogenesis, the formation of new blood vessels, is the process of generating neovascularization from preexisting vessels. It can promote tumor growth and metastasis by providing nutrients and oxygen. Integrin αvβ3 has been shown to play an important role in angiogenesis and up-regulated obviously in various types of tumor cells and activated endothelial cells. Since the arginine-glycine-aspartic acid (RGD) tripeptide sequence can bind to integrin αvβ3 with high affinity and specificity, RGD PET/CT may be helpful to evaluate the biological and metabolic activity status during angiogenesis. However, 18F-ALF-NOTA-PRGD2 PET/CT as response biomarker for antiangiogenic therapy has not been fully proved and is still without universal understanding according to current publications. Apatinib (YN968D1) is the first orally antiangiogenic drug targeting VEGFR-2 tyrosine kinase.In the current study, investigators propose to evaluate the feasibility of 18F-RGD PET/CT in monitoring efficacy and adverse events of apatinib in malignancies. Patients confirmed malignancies histopathologically will be prospectively enrolled in the study. All patients provided written informed consent prior to enrollment. Patients will receive apatinib therapy, and undergo 18F-RGD PET/CT scans berore and after first cycle of therapy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of malignancies
  • Scheduled for second- or third-line apatinib therapy
  • Karnofsky performance status (KPS) ≥70
  • Measurable primary tumors according to Response Evaluation Criteria in Solid Tumors (RECIST)

排除标准

  • Active infection, myocardial infarction within 6 months, symptoms of heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive therapy
  • The claustrophobic patients and patients with implanted metal objects
  • The pregnancy
  • Inability to complete the required examinations

研究组 & 干预措施

Apatinib & RGD PET/CT

Experimental

All of the patients will receive apatinib at oral dose of 250 mg twice daily (500 mg/day) at least 30 days.One treatment cycle is defined as 4 weeks.18F-ALF-NOTA-PRGD2 PET/CT scan will be performed berore and after one cycle of therapy. Treatment interruptions or dose reductions to 250 mg/day will be allowed for the management of adverse events. The maximum allowable period of treatment interruption is 1 week during each treatment cycle, and the dose should be re-escalated to 500 mg/day after adverse events mitigation. Treatment will not stop until disease progression, intolerable toxicity, or patients' request for withdrawal from the study.

干预措施: Apatinib (Drug)

结局指标

主要结局

Tumor response defined by RECIST criteria

时间窗: At 1 month of the study

Tumor response will be evaluated as complete response or partial response or stable disease or PD according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

次要结局

  • Days from the start of therapy to disease progression or death due to any cause(At 6 months of the study)
  • Days from the start of therapy to death due to any cause(Up to 12 months)
  • Treatment-Related Adverse Events as Assessed by CTCAE(Through study completion, an average of 6 months)

研究者

发起方
Shandong Cancer Hospital and Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

ShuanghuYuan

M.D., Ph.D.

Shandong Cancer Hospital and Institute

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