Official Title ICMJE A Phase 2, Open-Label, Multi-Center, Single Arm Study to Evaluate the Efficacy and Safety of TACE Sequential Tislelizumab as Adjuvant Therapy in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 2-year Recurrence Free Survival Rate (2-year RFS rate)
研究概览
简要总结
This is an open label, multi-center, phaseⅡstudy to evaluate the efficacy and safety of TACE sequential tislelizumab as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after curative resection.
详细描述
Hepatocellular carcinoma (HCC) is a malignant tumor with high morbidity and mortality. Surgical resection is the most important radical treatment. However, the recurrence rate is high especially in the patients with high risk of recurrence after curative resection. How to reduce postoperative recurrence and improve survival is currently a direction that is worth exploring.
Until now there is no standard postoperative adjuvant therapy. Previous studies have shown that TACE combined with PD-1 inhibitors has a synergistic enhancement effect, and this study is to explore the efficacy and safety of TACE sequential tislelizumab as adjuvant therapy in HCC patients who are at high risk of recurrence after curative resection.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a histopathological or cytologically diagnosis of HCC
- •Subjects who have undergone a curative resection
- •High risk for HCC recurrence as protocol defined
- •No previous systematic treatment and locoregional therapy for HCC
- •Child-Pugh Score, Class A
- •ECOG performance status 0 or 1
- •Full recovery from surgical resection
- •Adequate organ function
- •Absence of major macrovascular invasion
- •No extrahepatic spread
- •Life expectancy of at least 6 months
排除标准
- •Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
- •Evidence of residual, recurrent, or metastatic disease
- •Known history of serious allergy to any monoclonal antibody
- •History of hepatic encephalopathy
- •Tumor thrombus in portal vein or superior mesenteric vein or inferior caval vein
- •Portal hypertension with bleeding esophageal or gastric varices within 6 months prior to initiation of treatment
- •Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment
- •Any active malignancy within 2 years prior to the start of treatment
- •Active or history of autoimmune disease
- •Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation
- •Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or other immunotherapy
- •Pregnant or lactating women
研究组 & 干预措施
Postoperative TACE + Tislelizumab 200mg IV Q3W
TACE will be performed after curative resection (4±1w) once and then Tislelizumab Injection will be initiated after TACE (5±2d). Tislelizumab will be administered every three weeks, until the disease recurrence, intolerable toxicity, death, withdrawal of consent or completion of 17 cycles of Tislelizumab.
干预措施: Tislelizumab (Drug)
Postoperative TACE + Tislelizumab 200mg IV Q3W
TACE will be performed after curative resection (4±1w) once and then Tislelizumab Injection will be initiated after TACE (5±2d). Tislelizumab will be administered every three weeks, until the disease recurrence, intolerable toxicity, death, withdrawal of consent or completion of 17 cycles of Tislelizumab.
干预措施: TACE (Drug)
结局指标
主要结局
2-year Recurrence Free Survival Rate (2-year RFS rate)
时间窗: Observation period 24 months
2-year RFS rate is defined as the proportion of patients alive and free of recurrence at 2 years after curative resection.
次要结局
- Recurrence-Free Survival (RFS)(24 months)
- Time to recurrence (TTR)(24 months)
- Overall Survival (OS）(24 months)
- 1-year RFS rate(12 months)
- 1-year OS rate/2-year OS rate(12 months/24 months)
- Adverse Events (AEs)(24 months)
研究者
TingBo Liang
Professor
Zhejiang University