Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion: A Multicenter, Phase III, Randomized Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Recurrence-Free Survival (RFS)
研究概览
简要总结
To compare the impact on recurrence risk of adjuvant Sintilimab (a recombinant fully human anti-PD-1 monoclonal antibody) for patients with hepatocellular carcinoma and microvascular invasion (MVI) after hepatectomy.
详细描述
This study is a prospective, multicenter, open-label, randomized controlled clinical trial, aiming to recruit 360 patients with MVI-positive HCC who have undergone surgical resection. The patients will be randomly divided into three groups: the first group will receive six months of adjuvant therapy with Sintilimab (200 mg every three weeks for a total of 9 cycles), the second group will receive one year of adjuvant therapy with Sintilimab (200 mg every three weeks for a total of 18 cycles), and the Active surveillance group will be closely followed postoperatively. A maximum of one postoperative adjuvant TACE is permitted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Subjects with a histopathological diagnosis of HCC
- •Undergone a curative resection
- •Pathologically confirmed HCC with microvascular invasion (MVI)
- •Aged 18-75 years
- •No previous systematic treatment and locoregional therapy for HCC prior to randomization
- •Absence of major macrovascular invasion
- •No extrahepatic spread
- •Full recovery from Curative resection within 4 weeks prior to randomization
- •Child-Pugh: Grade A or B(7)
- •ECOG-PS score: 0 or 1
- •Subjects with HCV- RNA (+) must receive antiviral therapy
- •Adequate organ function
排除标准
- •Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinom or recurrent HCC
- •Any preoperative treatment for HCC including local and systemic therapy
- •Have received more than 1 cycle of adjuvant TACE following surgical resection
- •Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency
- •Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug
- •Subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy
- •Cardiac clinical symptom or cardiovascular disease that is not well controlled
- •Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
- •Any persistent serious surgery-related complications; esophageal and/or gastric variceal bleeding within 6 months
- •Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
- •Inability or refusal to comply with the treatment and monitoring
研究组 & 干预措施
Sintilimab for six months group (9 cycles)
Patients receive Sintilimab at a dose of 200 mg via intravenous injection, with one cycle every three weeks, for a total of 9 cycles or until disease recurrence or intolerable adverse effects occurred.
干预措施: Sintilimab (9 cycles) (Drug)
Sintilimab for one year group (18 cycles)
Patients receive Sintilimab at a dose of 200 mg via intravenous injection, with one cycle every three weeks, for a total of 18 cycles or until disease recurrence or intolerable adverse effects occurred.
干预措施: Sintilimab (18 cycles) (Drug)
Active surveillance
Patients are closely monitored postoperatively.
干预措施: Active surveillance (Other)
结局指标
主要结局
Recurrence-Free Survival (RFS)
时间窗: Randomization up to 60 months
RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by BIRC, or death from any cause (whichever occurs first).
次要结局
- Overall Survival (OS)(Randomization up to 60 months)
- RFS Rate at 12 ,24 , 36 , 60 Months(Randomization up to 60 months)
- Quality of Life (QoL) Scale Score(Baseline up to 60 months)
- Adverse events(Baseline up to 60 months)