A Single Arm Pilot Study of Programmed Cell Death Drotein 1 Antibody (PD-1） SHR-1210 Combined With Apatinib Mesylate in Patients With Intermediate And Advanced-Stage Hepatocellular Carcinoma After Radical Hepatectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- relapse-free survival(RFS)
研究概览
简要总结
SHR-1210 is a humanized anti-PD1 Immunoglobulin G4 (IgG4) monoclonal antibody. This is an open- label，single center ，non-randomized ，Single Arm Exploratory Study . This clinical study is an investigator-initiatedclini-cal trial（IIT ）.The objective of this study is to evaluate the efficacy and safety of adjuvant therapy with anti-PD-1 antibody SHR-1210 and apatinib in patients with Barcelona Clinic Liver Cancer (BCLC) B&C stage hepatocellular carcinoma after surgery.
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 femal.
- •Hepatocellular carcinoma confirmed by histopathology, Child-Pugh A .
- •BCLC staging is stage B or C, preoperative assessment of no extrahepatic metastases.
- •ECOG Performance Status 0-
- •Alpha-fetoprotein (AFP) decreased to normal，3-4 weeks after surgery. If it is not normal, it must be checked that there is no clear lesion in MRI or CT.
- •Adequate organ function.
- •Patient has given written informed consent.
排除标准
- •No anti-tumor treatment for hepatocellular carcinoma, including chemotherapy and topical treatment, before surgery.
- •Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation.
- •Tumors are not completely removed, or postoperative pathology suggests non-hepatocellular carcinoma or other malignant components;
- •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
SHR-1210+ apatinib
SHR-1210 (200mg fixed dose every 3 weeks, one cycle is three weeks, total
1 year ) will be administered as an intravenous infusion over 30 minutes.
apatinib 250 mg qd ， one cycle is three weeks, total 1 year
干预措施: SHR-1210 (Drug)
SHR-1210+ apatinib
SHR-1210 (200mg fixed dose every 3 weeks, one cycle is three weeks, total
1 year ) will be administered as an intravenous infusion over 30 minutes.
apatinib 250 mg qd ， one cycle is three weeks, total 1 year
干预措施: apatinib (Drug)
结局指标
主要结局
relapse-free survival(RFS)
时间窗: 1 year
from the date of enrollment to tumor recurrence or Death
Overall survival(OS)
时间窗: 3 years
the date of Death of any causes since the date of enrollment
次要结局
未报告次要终点