Lenvatinib, Sintilimab Plus Y-90 Selective Internal Radiation Therapy for Patients With Unresectable Intermediate-advanced Hepatocellular Carcinoma: a Prospective, Single-center, Single Arm Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS) according to mRECIST
研究概览
简要总结
This study is conducted to evaluate the efficacy and safety of lenvatinib, sintilimab plus Y-90 selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC).
详细描述
This is a single-center, prospective study to evaluate the efficacy and safety of lenvatinib, sintilimab plus SIRT (Len-Sin-SIRT) in patient with unresectable HCC.
30 patients with unresectable intermediate-advanced HCC (BCLC B/C stage) will be enrolled in this study. The patients will receive lenvatinib (body weight ≥60kg, 12mg; body weight <60kg, 8mg; P.O. QD) and sintilimab (200mg I.V. Q3W) at 3-7 days after SIRT. Sintilimab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Lenvatinib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first.
The primary end point of this study is Progression free survival (PFS) per mRECIST. The secondary endpoints are PFS per RECIST 1.1, objective response rate (ORR), disease control rate (DCR), overall survival (OS) and adverse events (AEs).
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
- •Unresectable HCC (BCLC stage B/C) with diagnosis confirmed by histology/cytology or clinically
- •At least one measurable untreated lesion
- •Intrahepatic tumors can be treated with 1-2 session of SIRT
- •Child-Pugh score 5-7
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- •Life expectancy of at least 3 months
- •Patients with active hepatitis B are allowed, but they need to receive antiviral treatment to achieve a HBV DNA<10^3 IU/mL
- •Patients with hepatitis C need to finish the anti-HCV treatment
排除标准
- •tumor extent ≥70% liver occupation
- •Tumor thrombus involving main portal vein or both the first left and right branch of portal vein
- •Vena cava invasion
- •Central nervous system metastasis
- •Metastatic disease that involves major airways or blood vessels
- •Patients who previously received hepatic arterial infusion chemotherapy (HAIC), transarterial chemoembolization (TACE), transarterial embolization (TAE), radiotherapy, systemic therapy, or immunotherapy for HCC
- •History of organ and cell transplantation
- •Prior esophageal and/or gastric varices bleeding
- •History of hepatic encephalopathy
- •Peripheral blood white blood cell count<3×10^9/L, platelet count<50×10^9/L
- •Prolongation of prothrombin time ≥ 4 seconds
- •Severe organ dysfunction (heart, lungs, kidneys)
- •History of malignancy other than HCC
- •HBsAg and anti-HCV antibody positive concurrently
- •Human immunodeficiency virus (HIV) infected
研究组 & 干预措施
Len-Sin-SIRT
Lenvatinib, sintilimab plus SIRT
干预措施: Lenvatinib, sintilimab plus SIRT (Drug)
结局指标
主要结局
Progression free survival (PFS) according to mRECIST
时间窗: 2.5 years
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
次要结局
- Overall survival (OS)(2.5 years)
- Adverse Events (AEs)(2.5 years)
- Progression free survival (PFS) according to RECIST 1.1(2.5 years)
- Objective response rate (ORR)(2.5 years)
- Disease control rate (DCR)(2.5 years)