NCT04564313Unknown1 期
Clinical Study of Anti-PD-1 Antibody Camrelizumab in the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplantation
Third Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年9月21日最近更新:
适应症
干预措施
相关药物
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
- Objective Response Rate (ORR)
研究概览
简要总结
This is a prospective clinical study to investigate the safety and efficacy of anti-PD-1 immunotherapy (Camrelizumab) in patients with recurrent hepatocellular carcinoma (HCC) after liver transplantation. All of the enrolled patients have a background of liver transplantation for HCC. Due to the tumor recurrence, patients are not suitable for curative surgical resection, and targeted therapy provides poor therapeutic effect, leading to tumor progression or intolerance. Before immunotherapy, the PD-L1 expression was confirmed negative in the graft liver by immunohistochemistry, and patients continued targeted therapy as part of a combined antitumor regimen. In addition, the immunosuppression schedule is also reduced to a low level.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years old, male or female;
- •Pathologically confirmed hepatocellular carcinoma after liver transplantation;
- •Tumor recurrence or metastasis is confirmed by CT and/or MRI examination, and neither intrahepatic recurrence nor extrahepatic metastasis is suitable for surgical resection;
- •At least one measurable recurrent or metastatic tumor lesion;
- •Tumor progression (mRECIST) or intolerance to treatment was assessed at least 1 month after oral administration of sorafenib or lenvatinib;
- •The expected survival time is more than 3 months;
- •Child-Pugh grade A or B (≤7 points);
- •Other vital organs' function: The absolute count of neutrophils ≥1.5×10E9/L; Platelet ≥50×10E9/L; Hemoglobin ≥9g/dL; Serum albumin ≥2.8g/dL; Thyroid stimulating hormone (TSH) ≤1 times ULN (If TSH is abnormal, T3 and T4 levels should be examined at the same time. Then, if both T3 and T4 levels are normal, patient could be enrolled); Bilirubin ≤1.5 times ULN; ALT and AST ≤3 times ULN; Serum creatinine ≤1.5 times ULN;
- •ECOG score 0-2 points;
- •Patients have sufficient understanding and voluntarily sign the informed consent, and are willing and able to comply with the visit, treatment plan, laboratory examination and other requirements of the study schedule.
排除标准
- •Positive PD-L1 expression in liver biopsy by immunohistochemistry (either liver parenchyma or non-parenchymal cells);
- •Be Allergic to Camrelizumab;
- •≥ Grade II myocardial ischemia or myocardial infarction;
- •With hypertension that can't be controlled to normal level with medication (SBP >140mmHg, DBP >90mmHg);
- •With abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L), and with a history of gastrointestinal bleeding within 6 months;
- •With high risk of bleeding or is receiving thrombolysis or anticoagulant therapy;
- •With autoimmune diseases including systemic lupus erythematosus, rheumatoid arthritis, psoriasis, etc;
- •The primary liver disease for liver transplantation was autoimmune hepatitis, primary biliary cirrhosis, or primary sclerosing cholangitis;
- •With pulmonary diseases such as interstitial pneumonia and poor lung function;
- •Participating in clinical trials of other experimental drugs within four weeks;
- •With infections requiring systemic treatment;
- •With positive infection of human immunodeficiency virus (HIV);
- •Special groups that not recommended in the instructions of Camrelizumab: with moderate or severe insufficiency of liver and renal function;
- •With MDM2/4 amplification, EGFR mutation, or JAK mutation by NGS sequencing;
- •With other factors that may influence the safety or compliance;
- •During the treatment of acute rejection or within 1 month after treatment;
- •Poor compliance.
研究组 & 干预措施
Camrelizumab treatment
Experimental
Camrelizumab (SHR-1210), 200mg, I.V., Q3W
干预措施: Camrelizumab treatment (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 2 years
Objective Response Rate after Camrelizumab treatment according to the mRECIST
次要结局
- Overall Survival (OS)(2 years)
- Serious Adverse Event (SAE)(2 years)
- Graft Rejection (GR)(2 years)
- Progression-free Survival (PFS)(2 years)
- Time to Progression (TTP)(2 years)
研究者
Wang Guoying
M.D.
Third Affiliated Hospital, Sun Yat-Sen University
研究点 (1)
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