NCT04277221Unknown3 期
Autologous Dendritic Cell / Tumor Antigen (ADCTA-SSI-G1) for Adjuvant Immunotherapy in Standard Treatment of Recurrent Glioblastoma Multiforme (GBM): A Multi-center, Open-label, Randomized Phase III Clinical Trial
Safe Save Medical Cell Sciences & Technology Co.,Ltd.14 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2019年9月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 118
- 试验地点
- 14
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
To confirm the result of previous Phase I/II and phase II clinical trials, this trial is to test the efficacy and safety of ADCTA immunotherapy plus the standard therapy in comparison with standard therapy alone in patients with recurrent GBM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Specimen collection screening
- •Karnofsky performance status (KPS) ≥ 60 at assessment prior to surgery
- •≥ 18 and ≤ 70 years of age
- •Subject has been diagnosed with GBM and has undergone resection surgery followed by standard brain RT + concurrent temozolomide and adjuvant temozolomide, and progression occurred. The foregoing progression is defined as when patients with primary GBM experience an image or clinical deterioration after receiving standard of care.
- •Contrast-enhanced MRI suspects recurrent GBM
- •Supratentorial tumor
- •Must voluntarily sign and date informed consent form for specimen acquisition and future use, for study screening, approved by an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any study-specific procedures
- •Study screening
- •Karnofsky performance status (KPS) ≥ 60 at randomization
- •Submission of fresh tumor
- •Post-operation contrast-enhanced MRI scan must be done after surgical resection, with the intent for cyto-reduction ≥ 80% of the contrast-enhancing tumor mass
- •Histologically confirmed WHO grade IV glioma by pathology tissue screening
- •Subjects receiving bevacizumab as standard of care for given indication
- •Subject has adequate bone marrow, renal, and hepatic function prior to randomization as follow:
- •White blood cell (WBC) count ≥ 2,000/mm^3;
- •Absolute neutrophil count (ANC) ≥ 1,000/mm^3;
- •Platelets ≥ 100,000/mm^3;
- •Hemoglobin (Hgb) ≥ 8.0 g/dL (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable.);
- •Blood Urea Nitrogen (BUN) < 30 mg/dL;
- •Creatinine < 2 mg/dL;
- •Renal function: calculated creatinine clearance ≥ 30 mL/min;
- •Hepatic function: Total bilirubin ≤ 3 times upper limit of normal (ULN), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2 times ULN;
- •Prothrombin Time (PT) and activated partial thromboplastin time (PTT) ≤ 1.6 times ULN unless therapeutically warranted.
- •Subjects with recurrent GBM (Grade IV) are eligible for this protocol. An independent neuropathologist will review this diagnosis during the enrollment process
- •Must voluntarily sign and date informed consent form, for study participation, approved by an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any study-specific procedures
排除标准
- •Specimen collection screening
- •Multifocal GBM
- •Prior invasive malignancy (except for non-melanomatous skin cancer; carcinoma in situ of breast, oral cavity or cervix) unless disease free for ≥ 2 years
- •Subject has used bevacizumab or immune checkpoint blockade to treat GBM
- •Lactating or pregnant female
- •Positive viral serology for HIV or syphilis at time of screening
- •Study screening
- •Subjects having a biopsy only at surgery or tumor cell insufficiency at preparation
- •Inability to undergo contrast-enhanced MRI scans
- •Subjects receiving investigational study drug for any indication or immunological-based treatment for any reason (Filgrastim may be used for prevention of severe neutropenia)
- •Inability to stop or decrease the use of corticosteroid doses to 4 mg/day prior to randomization
- •Tumor progression documented according to modified RANO criteria prior to randomization (approximately 5 weeks after surgery)
- •Severe, active comorbidity, defined as follow:
- •Subject with clinically defined Acquired Immune-Deficiency Syndrome (AIDS)-defining illness;
- •Subjects with acute hepatitis C or B infection;
- •Severe hepatic impairment (Child-Pugh category C or higher);
- •Electrocardiogram (ECG) with evidence of acute cardiac ischemia prior to randomization;
- •Transmural myocardial infarction or ischemia prior to enrollment;
- •Any other major medical illnesses or psychiatric impairments that in the Investigator's opinion will prevent administration or completion of protocol therapy
- •Subject used Gliadel wafer implant in surgery during screening process
结局指标
主要结局
Overall Survival (OS)
时间窗: The duration will be calculated from the date of randomization until the date of death from any cause, assessed up to 60 months.
次要结局
- Progression-free Survival at 6 months (PFS6)(The duration will be calculated from the date of randomization to the date of the sixth month.)
- Progression-free Survival (PFS)(The duration will be calculated from the date of randomization until the date of first documented progression according to the modified RANO or date of death from any cause, whichever came first,assessed up to 60 months.)
- 1 and 2-year Survival Rate(The duration will be calculated from the date of randomization to the date of the first year and the second year.)
研究者
研究点 (14)
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