Evaluation of PD-1 Inhibition in Patients With Recurrent Hepatocellular Carcinoma After Liver Transplantations
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Serious Adverse Event Rate
研究概览
简要总结
This is a perspective clinical study to assess the safety and efficacy of PD-1 inhibitors in patients with LT. Eligible patients have recurrent or metastatic cancer after LT, are not amenable to, or refractory after, locoregional therapy or to a curative treatment approach (eg, surgery, or ablation) and have previously been treated with sorafenib or other targeted therapy, either intolerant to this treatment or show radiographic progression after treatment.
Biopsy is needed to exclude patients with positive allograft PD-L1 expression.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with recurrence or metastases Hepatocellular carcinoma after liver transplantation that not suitable for surgical resection and Local treatments such as radiofrequency ablation, transcatheter arterial embolization and radiotherapy, been treated with sorafenib or other targeted therapy and are either intolerant to this treatment or show radiographic progression after treatment.
- •Age 18-70 years old, male or female
- •Biopsy shows negative allograft PD-L1 expression
- •Child-Pugh score ≤ 6 points (Child-Pugh A)
- •Estimated postoperative survival time ≥ 12 weeks
- •ECOG score 0-1 points
- •Laboratory test indicators: white blood cells ≥ 3.0 × 109 / L, platelets ≥ 80 × 109 / L, hemoglobin ≥ 100g / L; total bilirubin ≤ 2.5 times the upper limit of normal, transaminase (AST, ALT) ≤ 2.5 times Upper limit of normal value, serum creatinine ≤ 1.5 times normal upper limit
- •Have sufficient understanding and voluntarily sign informed consent to participate in clinical research
排除标准
- •Biopsy shows positive allograft PD-L1 expression
- •Severe allergic reactions to other monoclonal antibodies
- •Have any history of active autoimmune diseases or autoimmune diseases
- •The presence of active infection with Hepatitis B or Hepatitis C Virus
- •Severe cardiopulmonary dysfunction patients, have high blood pressure and blood pressure can not be controlled with drugs, unstable coronary artery disease (uncontrollable arrhythmia, unstable angina), non-compensatory congestive heart failure, within 6 months Myocardial infarction
研究组 & 干预措施
treatment
JS001（PD-1 inhibitor）, 240mg I.V. Q3W,
干预措施: JS001(PD-1 inhibitor) (Drug)
结局指标
主要结局
Serious Adverse Event Rate
时间窗: 1.5 years
the occurrence rate of serious adverse event after PD-1 inhibitor treatment
Acute Graft Rejection Rate
时间窗: 1.5 years
the occurrence rate of acute graft rejection after PD-1 inhibitor treatment
次要结局
- Objective Response Rate(3 years)
- Progression Free Survival Rate(3 years)
- Over all survival Rate(3 years)
研究者
Jian Zhou
Professor
Shanghai Zhongshan Hospital