NCT03955354Unknown2 期
A Phase II Study of PD-1 Antibody SHR-1210 Combined With Apatinib of First-line Treatment of Advanced Acral Melanoma
Peking University Cancer Hospital & Institute2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年3月5日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- ORR
研究概览
简要总结
the investigators launched this exploratory study to evaluate the objective response rate (ORR) of SHR-1210 combined with apatinib mesylate in the first-line treatment of patients with advanced acral 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
- •age:18-75 years, male or female.
- •Histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage III/IV).
- •Has not received any systematic anti-tumor drug treatment.
- •Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.
- •Adequate organ function.
- •Life expectancy of greater than 12 weeks.
- •Patient has given written informed consent.
排除标准
- •Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
- •Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation.
- •Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
- •Subjects with any active autoimmune disease or history of autoimmune disease
- •Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
- •Active infection or an unexplained fever > 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
- •Received a live vaccine within 4 weeks of the first dose of study medication.
- •Pregnancy or breast feeding.
- •Decision of unsuitableness by principal investigator or physician-in charge.
研究组 & 干预措施
experimental arm
Experimental
SHR1210 plus apatinib
干预措施: SHR1210 (Drug)
experimental arm
Experimental
SHR1210 plus apatinib
干预措施: apatinib mesylate (Drug)
结局指标
主要结局
ORR
时间窗: Time Frame: Through study completion, an average of 1 year
Objective Response Rate
次要结局
未报告次要终点
研究者
Jun Guo
Associate Director of Peking University Cancer Hospital
Peking University Cancer Hospital & Institute
研究点 (2)
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