Clinical Study of SHR-1210 Plus Apatinib in Patients With Advanced Mucosal Melanoma Whose Diseases Progress After Chemotherapy
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- objective response rate
研究概览
简要总结
There is still no effective treatment for advanced mucosal melanoma at present. The efficacy of single-agent PD-1 inhibitors is less than 20%. It is urgent to explore regimens to improve the efficacy of PD-1 inhibitors in patients with advanced mucosal melanoma. This study is performed to explore the safety and efficacy of apatinib plus SHR-1210 in patients with advanced mucosa melanoma whose diseases progress after chemotherapy.
详细描述
Apatinib is an oral small molecule anti-angiogenesis inhibitors. It inhibits VEGFR-2 tyrosine kinase activity, thereby blocking VEGF-induced signaling and exerting a strong inhibitory effect on tumor angiogenesis.Apatinib has shown anti-melanoma activity in retrospective study. However, the efficacy is still very low. SHR-1210 is an anti-PD-1 antibody produced by Hengrui Pharmaceutical Co., Ltd. Apatinib plus SHR-1210 has shown synergy in several malignancies. This study is conducted to explore the efficacy and safety in advanced mucosa melanoma
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mucosal melanoma by pathology
- •expected lifespan ≥ 3 months
- •failure after one kind of chemotherapeutic regimen
- •at least one measurable lesion by RECIST 1.1
- •enough organ function
- •blood pressure is normal; for patients with hypertension the blood pressure should be controlled in normal by antihypertensive drugs
- •no other serious diseases conflicting with this regimen
- •no history of other malignancies
- •pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
- •informed consent from the patient
排除标准
- •Suffering from serious infectious diseases within 4 weeks before enrollment
- •requiring intermittent use of bronchodilators or medical interventions
- •usage of immunosuppressants before enrollment and the dose of immunosuppressant used ≥ 10mg / day oral prednisone for more than 2 weeks
- •serious allergy
- •serious mental diseases
- •abnormal coagulation funtion,bleeding tendency or receiving thrombolytic or anticoagulant therapy
- •abdominal fistula, gastrointestinal perforation, or abdominal abscess within 4 weeks prior to enrollment
- •previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe lung damage, etc.
- •other situations evaluated by investigator unsuitable for this study
研究组 & 干预措施
treatment group
apatinib 250mg orally once a day until disease progression of occurrence of intolerable adverse events.
SHR-1210 200mg every two weeks until disease progression of occurrence of intolerable adverse events.
(the first dose of SHR-1210 is set on the 3-5 days after apatinib
干预措施: apatinib plus SHR-1210 (Drug)
结局指标
主要结局
objective response rate
时间窗: three months
the proportion of patients with CR, PR, and SD in the group
次要结局
- progression-free survival(six months)
- overall survival(eighteen months)