Preoperative Anti-PD-1 Antibody Plus Drug-eluting Bead TACE for BCLC Stage A/B Hepatocellular Carcinoma Beyond the Milan Criteria: A Phase II Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS) per mRECIST
研究概览
简要总结
This study aimed to evaluate the efficacy and the safety of the anti-programmed-death-1 antibody (anti-PD-1) Sintilimab Injection in combination with transarterial chemoembolization with drug-eluting beads(TACE-DEB) in patients with BCLC Stage A/B Hepatocellular Carcinoma Beyond the Milan Criteria.
详细描述
Patients with hepatocellular carcinoma (HCC) of BCLC stage A/B exceeding the Milan criteria have a low resection rate and high postoperative recurrence rate, therefore, optimizing therapy for these patients is an important unmet need. This study aimed to investigate the efficacy and safety of preoperative DEB-TACE plus sintilimab for the treatment of patients with BCLC stage A/B HCC exceeding the Milan criteria.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
DEB-TACE+Sintilimab
Participants with BCLC Stage A/B Hepatocellular Carcinoma Beyond the Milan Criteria
干预措施: Sintilimab (Drug)
DEB-TACE+Sintilimab
Participants with BCLC Stage A/B Hepatocellular Carcinoma Beyond the Milan Criteria
干预措施: DEB-TACE (Drug)
结局指标
主要结局
Progression Free Survival (PFS) per mRECIST
时间窗: 36 months
The duration from treatment initiation to PD in patients who cannot undergo surgery, or to the date of postoperative relapse in patients who receive surgery, or death for any reason, whichever occurs first (according to mRECIST).
次要结局
- 12 mo PFS rate(36 months)
- Pathological Response(6 months)
- Disease Control Rate (DCR) per mRECIST(36 months)
- Overall survival (OS)(36 months)
- Objective Response Rate (ORR) per mRECIST(36 months)
- Adverse events (AEs)(36 months)
研究者
TingBo Liang
Clinical Professor
Zhejiang University