Clinical Study of Apatinib Mesylate Combined With Stereotactic Body Radiation Therapy in the Treatment of Oligometastasis of Breast Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The treatment of the patients with metastatic breast cancer remains a major problem. However, there is an intermediate state between the primary tumor and distant metastases called oligometastasis. Current research indicates that good local control of oligometastasis can be obtained with Stereotactic body radiotherapy (SBRT) Can not prolong the long-term survival of patients. Researchers believe that after SBRT treatment of patients with oligometacosis in breast cancer, it is necessary to explore whether the anti-angiogenic therapy targeted drug apatinib can reduce the occurrence of new lesions and prolong the survival of patients.
详细描述
The treatment of the patients with metastatic breast cancer remains a major problem. However, there is an intermediate state between the primary tumor and distant metastases called oligometastasis. Current research indicates that good local control of oligometastasis can be obtained with Stereotactic body radiotherapy (SBRT) Can not prolong the long-term survival of patients. Researchers believe that after SBRT treatment of patients with oligometacosis in breast cancer. So, through the detection of microRNA in the primary lesion of breast cancer patients with oligometastasis to screen the patients with oligomerization and potential multiple metastases; explore the existing medical treatment, based on the control of local lesions by SBRT, the use of apatinib anti-angiogenic targeted maintenance therapy, with a view to reducing the incidence of new lesions, thereby prolonging the patient's survival.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: ≥ 18 years old women;
- •Histologically confirmed breast cancer; 3 weeks before enrollment ECOG PS score: 0-2 points;
- •systemic metastasis lesions ≤ 5, Stereotactic body radiotherapy before receiving medical treatment to achieve partial relief or stable disease;
- •Appropriate hematological parameters and liver and kidney function: absolute neutrophil ≧ 1.5 × 109 / L; platelet count ≧ 75 × 109 / L; serum total bilirubin ≦ 1.5 × upper limit of normal; AST and ALT ≦ 2.5 × upper limit of normal (if liver dysfunction)
- •Subject voluntarily joined the study and signed the informed consent form.
排除标准
- •After the above image examination of the whole body metastasis lesions ≥ 6;
- •Have received one or more palliative chemotherapy regulators failed;
- •Patients with a high risk of bleeding: active gastric digestive ulcer in the stomach with fecal occult blood (++); those with a history of melena and / or vomiting within 3 months; persons with abnormal coagulation and bleeding tendency; 3-4 grade hypertension patients;
- •Renal insufficiency 3 and above patients;
- •Hand-foot syndrome ≥ 3 or more patients;
- •There are uncontrolled concomitant diseases in the first 6 months of the study, including unstable angina pectoris, acute myocardial infarction, cerebrovascular accident and so on;
- •Pregnant or breastfeeding patients, or who have fertility without taking contraceptive measures;
- •A history of malignancy, but disease-free survival of more than 5 years;
- •Concurrent with other anti-cancer therapies or other interventional clinical trials;
- •Patients unable to follow the study due to psychological, family-living social reasons
研究组 & 干预措施
SBRT+apatinib group
Apatinib mesylate tablets: 500mg / day, 28 days / cycle, follow-up to the progress of the disease, toxicity intolerable or patients require withdrawal; SBRT: according to the different treatment sites given the corresponding dose: 1200cGy × 4 times or 800cGy × 7 times, or according to the specific situation dose adjustment.
干预措施: Apatinib (Drug)
SBRT+apatinib group
Apatinib mesylate tablets: 500mg / day, 28 days / cycle, follow-up to the progress of the disease, toxicity intolerable or patients require withdrawal; SBRT: according to the different treatment sites given the corresponding dose: 1200cGy × 4 times or 800cGy × 7 times, or according to the specific situation dose adjustment.
干预措施: SBRT (Radiation)
结局指标
主要结局
Overall survival (OS)
时间窗: Approximately 3 year
OS is defined as the length of time from random assignment to death or to last contact.
次要结局
- Progression-free Survival (PFS)(Approximately 2 year)
- Adverse Events(AEs)(Approximately 2 years)
研究者
Yan Li
assistant director physician
West China Hospital