Systemic PD-1 Antibody (Sintilimab) and Lenvatinib Plus Transarterial Chemoembolization and FOLFOX-based Chemotherapy Infusion for Potential Resectable HCC: a Single-arm, Phase 2 Clinical Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- conversion rate to resection
研究概览
简要总结
Hepatocellular carcinoma (HCC) is one of the most commonly malignant tumors around the world. Hepatic resection or liver transplantation is the radical method to cure the disease. However, less than 20% of newly diagnosed patients can undergo radical resection. Our latest study showed that 48% potentially resectable HCC received hepatectomy after transarterial chemoembolization plus FOLFOX-based chemotherapy infusion (TACE-HAIC) treatment. Recently, several clinical trials (LEAP-002) showed that PD-1 antibody and Lenvatinib had an ORR of 36% for advanced patients. The combination of TACE-HAIC with PD-1 antibody and lenvatinib, theoretically can significantly decrease the tumor burden and increase the hepatectomy rate. However, this hasn't been verified in clinical application. To identify a more effective and safety way for treating potentially resectable HCC patients, this study is designed to investigate TACE-HAIC plus PD-1 antibody and Lenvatinib will increase the resection rate for those patients.
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
- •Diagnosed as potentially resectable with consensus by the panel of liver surgeons
- •stage BCLC A/B/C, without extra-hepatic involvement
- •No previous anti-HCC treatment
- •Eastern Co-operative Group performance status 2 or less
- •Liver function: Child's A or B (score < 7)
排除标准
- •Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- •underlying serve cardiac or renal diseases Known or suspected allergy to the investigational agent or any agent given in association with this trial
- •Patients ineligible for hepatic artery embolization, or PD-1 antibody
研究组 & 干预措施
PD-1 antibody and lenvatinib plus TACE-HAIC
systemic PD-1 antibody (Sintilimab) and lenvatinib plus transarterial chemobolization and FOLFOX-based chemotherapy infusion
干预措施: PD-1 inhibitor (Drug)
结局指标
主要结局
conversion rate to resection
时间窗: 12 month
The conversion rate to resection among all the enrolled patients
次要结局
未报告次要终点
研究者
Yunfei Yuan
Professor
Sun Yat-sen University