HAIC Synchronously Combined With Bevacizumab and Toripalimab First-line for Advanced Hepatocellular Carcinama
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 主要终点
- Progression free survival rate at 6 months
研究概览
简要总结
This is an open-label, single-arm clinical study to preliminarily observe and evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin synchronous combined with Bevacizumab and Toripalimab as the first-line therapy for advanced HCC.
详细描述
Hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin was effective and safe for hepatocellular carcinoma. Bevacizumab, an angiogenesis Inhibitors was effectively used for hepatocelluar carcinama (HCC) therapy. Toripalimab, an programmed cell death protein-1 (PD-1) antibody, was effective and tolerable in patients with hepatocellular carcinoma and portal vein tumor thrombus. No study has evaluated HAIC plus Bevacizumab and Toripalimab. Thus, the investigators carried out this prospective, single-arm study to find out it.
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
- •HCC diagnosed by histopathological examination or Guidelines for Diagnosis and Treatment of Primary Liver Cancer or the recurrent HCC after surgery;
- •age between 18 and 75 years;
- •Stage B (middle stage) or C (late stage) HCC determined in accordance with Barcelona Clinic Liver Cancer staging system (BCLC stage). In case of stage B.
- •No previous use of any systemic therapy or recurrent HCC.
- •Child-Pugh class A or B;
- •Eastern Cooperative Group performance status (ECOG) score of 0-2;
- •Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
- •Prothrombin time ≤18s or international normalized ratio < 1.
- •Ability to understand the protocol and to agree to and sign a written informed consent document.
排除标准
- •Cholangiocellular carcinoma (ICC);
- •Patients with cancer thrombus in the main trunk of portal vein (Vp4), or cancer thrombus in inferior vena cava should be excluded;
- •Accepting ablation or surgery or other system therapy as firt line therapy after diagnose for primary HCC, ablation or system therapy as first line therapy for recurrent HCC.
- •Serious medical comorbidities.
- •Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- •Known history of HIV
- •History of organ allograft
- •Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- •Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- •Evidence of bleeding diathesis.
- •Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
研究组 & 干预措施
HAIC plus Bevacizumab and Toripalimab
Hepatic arterial infusion of oxaliplatin , fluorouracil, and leucovorin every 6 weeks. Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Toripalimab, 240 mg intravenously every 3 weeks. Bevacizumab 15 mg/kg intravenously every 3 weeks.
干预措施: Hepatic arterial infusion chemotherapy (Procedure)
HAIC plus Bevacizumab and Toripalimab
Hepatic arterial infusion of oxaliplatin , fluorouracil, and leucovorin every 6 weeks. Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Toripalimab, 240 mg intravenously every 3 weeks. Bevacizumab 15 mg/kg intravenously every 3 weeks.
干预措施: Bevacizumab (Drug)
HAIC plus Bevacizumab and Toripalimab
Hepatic arterial infusion of oxaliplatin , fluorouracil, and leucovorin every 6 weeks. Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Toripalimab, 240 mg intravenously every 3 weeks. Bevacizumab 15 mg/kg intravenously every 3 weeks.
干预措施: Toripalimab (Drug)
结局指标
主要结局
Progression free survival rate at 6 months
时间窗: 6 months]
Progression was defined as progressive disease by independent radiologic review according to mRECIST or death from any cause
次要结局
- Objective response rate (ORR)(6 months)
- Adverse events(6 months)
- Overall survival (OS)(6 months)
- Progression free survival (PFS)(6 months)
研究者
Zhou Qunfang
Clinical professor
Sun Yat-sen University