Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma: A Randomized Multicenter Prospective Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 464
- 试验地点
- 7
- 主要终点
- Progression-free survival
研究概览
简要总结
For patients with glioblastoma,postoperative radiotherapy combined with concurrent and adjuvant temozolomide (Stupp regimen) has long been considered a standard treatment approach.The treatment outcomes, however, are still dismal, with a median overall survival time of 8-12 months. As a novel small molecule multi-target tyrosine kinase inhibitor, anlotinib hydrochloride has been found to be able to inhibit both tumor angiogenesis and cell growth.Previous studies on recurrent glioblastoma have demonstrated its effectiveness in tumor control with manageable toxicities. The current study is designed to evaluate the efficacy and feasibility of the additional anlotinib hydrochloride to the Stupp regimen for newly diagnosed glioblastoma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed and histological proven glioblastoma
- •Complete gross resection or subtotal resection
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Adequate bone marrow, liver and renal function
- •Written informed consent
排除标准
- •Meningeal carcinomatosis or spinal compression
- •Patients who have previously received chemotherapy, targeted therapy, or anti-angiogenesis
- •Active, known, or suspected autoimmune disease
- •Severe allergy to anlotinib or temozolomide
- •Patient having acute hepatitis virus infection, active tuberculosis, or other acute infectious diseases
- •Uncontrolled mental disorders
- •High risk of bleeding
- •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%
- •Contraindicated for MRI examination
- •Recipient of live vaccine prior to the first dose of anlotinib
- •Ready for or previously received organ transplantation
研究组 & 干预措施
Radiation therapy, Temozolomide and anlotinib
Patients will receive standard radiation therapy plus temozolomide (Stupp regimen). Anlotinib hydrochloride will be given with a daily dose of 12 mg for 14 days of a 21-day cycle up to 2 cycles, initiated on the first day of radiation therapy and followed by adjuvant treatment with the same dosing schedule until patients have disease progression or intolerable toxicities.
干预措施: Anlotinib Hydrochloride (Drug)
Radiation therapy, Temozolomide and anlotinib
Patients will receive standard radiation therapy plus temozolomide (Stupp regimen). Anlotinib hydrochloride will be given with a daily dose of 12 mg for 14 days of a 21-day cycle up to 2 cycles, initiated on the first day of radiation therapy and followed by adjuvant treatment with the same dosing schedule until patients have disease progression or intolerable toxicities.
干预措施: Radiation therapy (Radiation)
Radiation therapy, Temozolomide and anlotinib
Patients will receive standard radiation therapy plus temozolomide (Stupp regimen). Anlotinib hydrochloride will be given with a daily dose of 12 mg for 14 days of a 21-day cycle up to 2 cycles, initiated on the first day of radiation therapy and followed by adjuvant treatment with the same dosing schedule until patients have disease progression or intolerable toxicities.
干预措施: Temozolomide (Drug)
Radiation therapy and temozolomide
Patients will receive standard radiation therapy plus temozolomide (Stupp regimen).
干预措施: Radiation therapy (Radiation)
Radiation therapy and temozolomide
Patients will receive standard radiation therapy plus temozolomide (Stupp regimen).
干预措施: Temozolomide (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 3 years
次要结局
- Objective response rate(3 years)
- Overall survival(3 years)
研究者
Heming Lu
Professor
People's Hospital of Guangxi