Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin Plus Lenvatinib and Toripalimab Versus Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin Plus Lenvatinib for Advanced Hepatocellular Carcinoma: a Phase 3, Randomized Controlled and Double-blind Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
Our previous study showed that hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab improved the survival of advanced hepatocellular carcinoma. However, Leep 002 study showded that lenvatinib plus PD-1 antibody is not superior to lenvatinib alone for advanced hepatocellular carcinoma. Thus, wo conduct this study to compare hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab with hepatic arterial infusion chemotherapy plus lenvatinib for advanced hepatocellular carcinoma.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
- •Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
- •Barcelona clinic liver cancer-stage C
- •Eastern Cooperative Oncology Group performance status of 0 to 2
- •With no previous treatment
- •No Cirrhosis or cirrhotic status of Child-Pugh class A only
- •Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
- •This study did not limit HBV DNA load. High HBV-DNA load was aollowed, but hepatitis-B patient must receive concurrent antiviral therapy.
- •The following laboratory parameters:
- •Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 30 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
- •Ability to understand the protocol and to agree to and sign a written informed consent document
排除标准
- •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.
- •Known central nervous system tumors including metastatic brain disease
研究组 & 干预措施
Experimental arm
Hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab
干预措施: Hepatic arterial infusion chemotherapy (Procedure)
Experimental arm
Hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab
干预措施: Lenvatinib (Drug)
Experimental arm
Hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab
干预措施: Toripalimab (Drug)
Experimental arm
Hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab
干预措施: oxaliplatin , fluorouracil, and leucovorin (Drug)
Control arm
Hepatic arterial infusion chemotherapy plus lenvatinib
干预措施: Hepatic arterial infusion chemotherapy (Procedure)
Control arm
Hepatic arterial infusion chemotherapy plus lenvatinib
干预措施: Lenvatinib (Drug)
Control arm
Hepatic arterial infusion chemotherapy plus lenvatinib
干预措施: oxaliplatin , fluorouracil, and leucovorin (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: 18 months
OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.
次要结局
- Objective Response Rate (ORR)(18 months)
- Progression Free Survival (PFS)(18 months)
- Adverse Events(30 days)
研究者
Shi Ming
Professor
Sun Yat-sen University