NCT05611645进行中（未招募）2 期
A Randomized Phase II Trial of Concurrent Low-dose Bevacizumab and HSRT Versus Bevacizumab Alone for Glioblastoma at First Recurrence: HSCK-005
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Progression-free Survival rate at 6 Months
研究概览
简要总结
This randomized phase II trial studies how well lose dose bevacizumab with Hypofractionated Stereotactic Radiotherapy (HSRT) works versus bevacizumab alone in treating patients with glioblastoma at first recurrence. The primary endpoint is 6-month progress-free survivaloverall survival after the treatment. Secondary endpoints included overall survival, objective response rate, cognitive function, quality of life and toxicity.
详细描述
To establish an improvement in 6-month pfs in recurrent glioblastoma patients receiving low-dose bevacizumab and re-irradiation compared with patients receiving bevacizumab alone.
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
- •18-70 years of age;
- •Karnofsky performance status (KPS) ≥ 60;
- •Original histopathologically proven diagnosis World Health Organization (WHO) Grade 3/4 glioma;
- •Underwent surgery, chemoradiotherapy and adjuvant chemotherapy (Stupp Protocol) after initial diagnosis, recurrent based on the Response Assessment in Neuro-Oncology (RANO) criteria and/or histopathologically proven;
- •Measurable disease;
- •Estimated survival of at least 3 months, maximal diameter on T1+C MRI ≤ 3.5 cm;
- •Hgb > 9 gm; absolute neutrophil count (ANC) > 1500/μl; platelets > 100,000; Creatinine < 1.5 times the upper limit of laboratory normal value; Bilirubin < 2 times the upper limit of laboratory normal value; serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) < 3 times the upper limit of laboratory normal value;
- •Signed informed consent form;
- •Agreed to participate the follow-up.
排除标准
- •Prior invasive malignancy unless disease free;
- •Received re-irradiation;
- •More than 3 relapses or evidence of subtentorial recurrent disease or tumor greater than 6 cm in maximum diameter;
- •Prior therapy with an inhibitor of vascular endothelial growth factor (VEGF) or VEGFR;
- •Pregnancy or or nursing mothers;
- •Participated in other trials after diagnosis of recurrent;
- •Influence factors toward oral medications;
- •Patients with CTCAE5.0 grade 3+ bleeding;
- •Suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval ≥ 450 ms, women ≥ 470 ms); according to NYHA criteria, grades III to IV Insufficient function, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) <50%;
- •Long-term unhealed wounds or fractures;
- •History of organ transplantation;
- •Serious diseases that endanger patients' safety or affect patients' completion of research,according to the researchers' judgment.
研究组 & 干预措施
HSRT+Low-dose Bevacizumab
Experimental
HSRT with low-dose bevacizumab every 2 weeks
干预措施: Hypofractionated Stereotactic Radiotherapy (Radiation)
HSRT+Low-dose Bevacizumab
Experimental
HSRT with low-dose bevacizumab every 2 weeks
干预措施: Bevacizumab (Drug)
Bevacizumab
Active Comparator
Bevacizumab every 2 weeks
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Progression-free Survival rate at 6 Months
时间窗: From randomization to six months
Prgression was defined using Response Assessment in Neuro-Oncology (RANO) Criteria. Progression-free at 6 months means patient alive without progression at 6 months. Survival rates are estimated by the Kaplan-Meier method.
次要结局
- Objective response rate(Bimonthly up to intolerance the toxicity or progressive disease (PD), up to approximately 24 months)
- Cognitive function(Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months)
- Overall Survival(From randomization to last follow-up, up to approximately 24 months)
- Progression-free Survival(From randomization to last follow-up, up to approximately 24 months)
- Number of Participants With Grade 3+ Toxicity rate(Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months)
- Quality of Life score (QoL)(Bimonthly up to intolerance the toxicity or PD, up to approximately 24 months)
研究者
Yun Guan
Physician, CyberKnife Center
Huashan Hospital
研究点 (1)
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