NCT04725214Unknown2 期

Anlotinib Combined With STUPP Protocol as First-line Regimen for MGMT Nonmethylated Glioblastoma: a Multicenter, Open-label, Single-arm, Phase II Clinical Trial

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点分布在 1 个国家目标入组 33 人开始时间: 2021年1月15日最近更新: 2021年1月26日

适应症

干预措施

试验速览

阶段: 2 期
发起方
入组人数: 33
试验地点: 1
主要终点: 1-year OS

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to test the efficacy and safety of Anlotinib in combination with STUPP regimen for MGMT promoter nonmethylated glioblastoma.

详细描述

For MGMT unmethylated glioblastoma patients undergoing STUPP regimen adjuvant therapy, during adjuvant chemotherapy, concurrent with anti-angiogenesis targeted therapy(Anlotinib capsule,d1-14).

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 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Aged 18-70 years,
•Histologically proven diagnosis of glioblastoma (WHO grade IV),
•Have received standard STUPP treatment plan,
•Gross resection or partial resection of the tumor (confirmed by MRI)> 50%,
•The pathological tissue specimens are detected as MGMT unmethylated,6.Karnofsky performance status ≥ 60,
•No previous radiotherapy, chemotherapy, immunotherapy or biotherapy 7.Adequate bone marrow function: Hemoglobin ≥ 100g/L，Platelets ≥ 80×109/L，Absolute neutrophil count (ANC) ≥ 1.5×109/L
•8.Adequate renal function: Serum creatinine ≤ 1.25 x UNL (upper normal limit) or creatinine clearance ≥ 60 ml/min 9.Adequate hepatic function: serum bilirubin ≤ 1.5 x UNL, AST and ALT ≤ 2.5 x UNL，ALP≤5x UNL 10.For females of child-bearing potential, negative serum pregnancy test within 14 days prior to registration. Women of childbearing potential and male participants must practice adequate contraception during participation in the study and within 8 weeks after the last administration of the drug 11.Able to provide written informed consent

排除标准

•Recurrent or multiple malignant gliomas
•Subtentorial glioblastoma or metastatic lesions outside the skull
•Have received radiotherapy, chemotherapy or other anti-tumor drugs for the disease before surgery
•Previously received radiation therapy for the head and neck cancer
•Have received any antibody treatment before
•Contraindication of radiotherapy and chemotherapy defined as follows: Acute bacterial or fungal infection，Unstable angina and/or congestive heart failure within the last 6 months，co-morbidity with immunosuppressive therapy
•Evidence of bleeding diathesis or coagulopathy
•Prior invasive malignancy (except for non-melanomatous skin cancer or carcinoma in situ of cervix)

研究组 & 干预措施

Experimental

For MGMT unmethylated glioblastoma, during temozolomide adjuvant, concurrent with anti-angiogenesis targeted therapy(Anlotinib capsule,d1-14)

干预措施: Anlotinib (Drug)

结局指标

主要结局

1-year OS

时间窗: from enrollment to death (for any reason).assessed up to 12 months

1-year overall survival

次要结局

PFS(from enrollment to progression or death (for any reason),assessed up to 24months)
OS(from enrollment to death (for any reason).assessed up to 24 months)
adverse event(from enrollment to death (for any reason).assessed up to 24 months)
Health-related quality of life(from enrollment to death (for any reason).assessed up to 24 months)
Neurocognitive function(from enrollment to death (for any reason).assessed up to 24 months)

研究者

发起方

Second Affiliated Hospital, School of Medicine, Zhejiang University

申办方类型

Other

责任方

Sponsor

研究点 (1)

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