NCT02998242已完成不适用
Apatinib in Combination With SBRT Treatment for Symptomatic Metastatic
Sichuan Provincial People's Hospital0 个研究点目标入组 40 人开始时间: 2016年5月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- biochemical disease free survival
研究概览
简要总结
To study safety and efficacy of apatinib in combination of radiotherapy in patients with symptomatic bony disease prostate cancer (SBPC), based on the potential synergistic antitumor activity between Apatinib and Stereotactic Body Radiation Therapy (SBRT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologic diagnosis of adenocarcinoma of the prostate
- •Metastatic and symptomatic prostate cancer (positive bone scan or measurable disease)
- •Patients must stop using any herbal product known to decrease PSA levels (eg., saw palmetto and PC-SPES) or any systemic or topical corticosteroid at least 4 weeks prior to screening. Progressive disease must be documented after discontinuation of these products.
- •Progressive disease after androgen deprivation (or hormone therapy). For patients with measurable disease, progression will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. For patients with progression in, or without any measurable disease, a positive bone scan and elevated PSA will be required.
- •Patients receiving bisphosphate therapy must have been on stable doses for at least 4 weeks with stable symptoms prior to enrollment.
- •No prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control prostate cancer).
- •Prior radiation therapy completed at least 4 weeks prior to enrollment. No prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.
排除标准
- •History of severe hypersensitivity reactions to drugs formulated with polysorbate
- •Patients with active autoimmune disease or a history of autoimmune disease that required systemic steroids or immunosuppressive medications, except for patients with vitiligo.
- •Prior therapy with any anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) antibody.
- •Active infection requiring therapy.
- •Concurrent medical condition requiring the use of systemic or topical corticosteroids; systemic or topical corticosteroids must be discontinued at least 4 weeks prior to enrollment. The use of inhaled corticosteroids is acceptable.
研究组 & 干预措施
RT with apatinib
Experimental
selected dose administered PO during and after SBRT
干预措施: Apatinib (Drug)
RT with apatinib
Experimental
selected dose administered PO during and after SBRT
干预措施: SBRT to symptomatic bony metastatic bony site(s) (Radiation)
RT alone
Active Comparator
symptomatic bony metastatic site(s) receive SBRT less than 5 fractions
干预措施: SBRT to symptomatic bony metastatic bony site(s) (Radiation)
结局指标
主要结局
biochemical disease free survival
时间窗: 2 years
次要结局
未报告次要终点
研究者
ming zeng, MD
Director of Cancer Center
Sichuan Provincial People's Hospital
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