Abscopal Effect of SBRT in Combination With rhGM-CSF and INF-α 2b for Metastatic Thymic Epithelial Tumors
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- The abscopal effect rate
研究概览
简要总结
The purpose of this study is to determine whether stereotactic body radiotherapy (SBRT) combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) and Peginterferon alfa-2b is safe, effective in the treatment of patients with metastatic thymic epithelial tumors.
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
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •Histologically proven Thymic epithelial tumors；
- •Stage IV according to UICC stage system(version 8,2017), at least with two evaluable abscopal lesions (≥1cm)（excluding intestinal metastasis）;
- •Evaluated as effective or stable disease after first-line chemotherapy or progressed after second-line chemotherapy (progression sites were no more than three sites);
- •ECOG performance status: 0-1;
- •Life expectancy ≥ 3 months.
- •Adequate baseline organ and marrow function: absolute neutrophil count greater than 1500 cells per μL, platelet concentration of greater than 50 000 per μL, total bilirubin less than 1•5 times the upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase less than 2•5 times the ULN, and serum creatinine less than 1•5 times the ULN;
- •Female subjects have a negative urine or serum pregnancy test within 1 week prior to treatment if of childbearing potential;
- •Asymptomatic subjects with brain metastasis can be included, but the sites of brain cannot be considered as target sites;
- •Asymptomatic subjects with bone metastasis can be included, but the sites of bone cannot be considered as target sites.
排除标准
- •Having received immunotherapy within 4 weeks prior to inclusion;
- •Allergic to GM-CSF, INF-α2b or diagnosed with immune system disease, receiving immunosuppressant, such as prednisone, dexamethasone, methylprednisolone, methotrexate, hydroxychloroquine, cyclophosphamide, azathioprine and so one;
- •receiving treatment of other trials;
- •Any unstable systemic disease, including active infection, symptomatic congestive heart failure,myocardial infarction onset six months before included into the group, unstable angina, and severe arrhythmia, uncontrolled chronic lung disease;
- •unwilling to sign consent;
- •Women in pregnancy or lactation;
- •Other malignancy except for non-melanoma carcinoma of the skin or in situ carcinoma of the cervix.
研究组 & 干预措施
SBRT+GM-CSF+INF-αb
Metastasis lesion will be treated with a SBRT of 30Gy/5F from day 1 to day 5 . Injection of Immunological Agenthuman recombined granulocyte-macrophage colony stimulating factor (125ug/m² per day) will be executed from day 1 to day 14 in this cycle.Subcutaneous injection of Peginterferon alfa-b2(90ug) will be executed in day8. Another metastasis lesion will be treated likewise concurrently with rhGM-CSF in a consecutive cycle. Injection of Peginterferon alfa-b2(90ug) will be executed in day8 of this cycle.
干预措施: rhGM-CSF，Peginterferon alfa-b2，radiation (Drug)
结局指标
主要结局
The abscopal effect rate
时间窗: up to 12 months
The proportion of patients with an abscopal response assessed after the initiation of treatment
次要结局
- Progression free survival(up to 60 months)
- Overall survival(up to 60 months)