NCT06089382尚未招募3 期
A Phase III Trial of Sintilimab Plus Lenvatinib in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis (PVTT) After Surgical Resection
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 104
- 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) plus Lenvatinib for patients with hepatocellular carcinoma and portal vein tumor thrombus (PVTT ) after hepatectomy.
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 portal vein tumor thrombus (PVTT)
- •Aged 18-75 years
- •No previous systematic treatment and locoregional therapy for HCC prior to randomization
- •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
- •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
- •Active or history of autoimmune disease
- •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 Plus Lenvatinib
Experimental
干预措施: Sintilimab (Drug)
Sintilimab Plus Lenvatinib
Experimental
干预措施: Lenvatinib (Drug)
TACE(one cycle) + active surveillance
Active Comparator
干预措施: Transarterial Chemoembolization (TACE) (Procedure)
结局指标
主要结局
Recurrence-Free Survival (RFS)
时间窗: Randomization up to approximately 36 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
- Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Scale Score(Baseline up to 36 months)
- Quality of Life (QoL) Scale Score(Baseline up to 36 months)
- RFS Rate at 12 and 24 Months(up to 24 months)
- Overall Survival (OS)(Randomization up to approximately 36 months)
- Adverse events (AEs)(Randomization up to approximately 36 months)
研究者
研究点 (1)
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