Lenvatinib, Sintilimab, and Drug-Eluting Beads Transarterial Chemoembolization With or Without Hepatic Arterial Infusion Chemotherapy for Hepatocellular Carcinoma >7 cm With Portal Vein Tumor Thrombus: A Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Time to progression (TTP)
研究概览
简要总结
This study is conducted to evaluate the efficacy and safety of lenvatinib plus sintilimab, transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (LEN+SIN+DEB-TACE+HAIC) versus lenvatinib plus sintilimab and DEB-TACE (LEN+SIN+DEB-TACE) for large hepatocellular carcinoma (> 7cm) with portal vein tumor thrombosis (PVTT).
详细描述
This is a multicenter, prospective and randomized study to evaluate the efficacy and safety of LEN+SIN+DEB-TACE+HAIC compared with LEN+SIN+DEB-TACE for unresectable large HCC (>7cm) with PVTT.
320 patients with large HCC (> 7cm) and PVTT will be enrolled in this study. The patients will receive either Len+DEB-TACE+HAIC or Len+DEB-TACE using an 1:1 randomization scheme. In the LEN+SIN+DEB-TACE+HAIC arm, the microcatheter will be reserved at the main hepatic tumor-feeding artery after DEB-TACE and chemotherapy drugs (oxaliplatin, fluorouracil and leucovorin; FOLFOX-based regimen) will be intra-arterially administered though the microcatheter. DEB-TACE+HAIC treatments can be repeated based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. In the LEN+SIN+DEB-TACE arm, patients will be treated with DEB-TACE alone. TACE treatment can be repeated based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. In both arms, lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. qd and sintilimab 200mg I.V. q3w will be started within 7 days after the first DEB-TACE+HAIC/DEB-TACE.
The primary end point of this study is time to progression (TTP). The secondary endpoints are tumor response (objective response rate and disease control rate), overall survival (OS), and adverse events (AEs).
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
- Single (Outcomes Assessor)
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
- •a confirmed diagnosis of HCC
- •the largest intrahepatic lesion >7 cm
- •presence of PVTT on imaging
- •tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment
- •Eastern Cooperative Oncology Group performance status ≤1
- •Child-Pugh class A/B
- •adequate hematologic and organ function, with leukocyte count>3.0×10^9/L, neutrophil count>1.5×10^9/L, platelet count≥75×10^9/L, hemoglobin 85 g/L, alanine transaminase and aspartate transaminase≤5×upper limit of the normal, creatinine clearance rate≤1.5×upper limit of the normal; prothrombin time prolongation ≤4 seconds
- •life expectancy of at least 3 months
排除标准
- •accompanied with vena cava tumor thrombus
- •central nervous system involvement
- •previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy
- •organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment
- •history of other malignancies
- •uncontrollable infection
- •history of HIV
- •history of organ or cells transplantation
研究组 & 干预措施
LEN+SIN+DEB-TACE+HAIC
Patients will receive the combination treatment of LEN+SIN+DEB-TACE+HAIC.
干预措施: LEN+SIN+DEB-TACE+HAIC (Combination Product)
LEN+SIN+DEB-TACE
Patients will receive the combination treatment of LEN+SIN+DEB-TACE.
干预措施: LEN+SIN+DEB-TACE (Combination Product)
结局指标
主要结局
Time to progression (TTP)
时间窗: 4 years
The time from date of randomization until the first occurrence of disease progression (according to mRECIST).
次要结局
- Objective response rate (ORR)(4 years)
- Disease control rate (DCR)(4 years)
- Overall survival (OS)(5 years)
- Adverse Events (AEs)(4 years.)