Lenvatinib Plus Programmed Cell Death Protein-1 (PD-1) Inhibitor Versus Lenvtinib Alone for Advanced Hepatocellular Carcinoma: a Multicentre Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 5
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with PD-1 antibody compared with lenvtinib Alone in patients with advanced hepatocellular carcinoma (HCC)
详细描述
Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma, and PD-1 antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has compared the efficacy and safety of lenvatinib plus PD-1 antibody and lenvatinib alone. Thus, the investigators carried out this prospective randomized control study to find out it.
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.
- •The following laboratory parameters:
- •Platelet count ≥ 75,000/μL
- •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
Lenvatinib Plus PD-1
Participants received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (>=) 60 kilogram (kg) or 8 mg based on the participant's body weight less than (<) 60 kg at baseline, orally, once daily (QD) in continuous 14-day treatment cycles, and received 3mg/kg PD-1 antibody intravenously every 2 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
干预措施: Lenvatinib (Drug)
Lenvatinib Plus PD-1
Participants received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (>=) 60 kilogram (kg) or 8 mg based on the participant's body weight less than (<) 60 kg at baseline, orally, once daily (QD) in continuous 14-day treatment cycles, and received 3mg/kg PD-1 antibody intravenously every 2 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
干预措施: PD-1 antibody (Drug)
Lenvatinib alone
Participants received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (>=) 60 kilogram (kg) or 8 mg based on the participant's body weight less than (<) 60 kg at baseline, orally, once daily (QD) in continuous 14-day treatment cycles, and received placebo intravenously every 2 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
干预措施: Lenvatinib (Drug)
Lenvatinib alone
Participants received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (>=) 60 kilogram (kg) or 8 mg based on the participant's body weight less than (<) 60 kg at baseline, orally, once daily (QD) in continuous 14-day treatment cycles, and received placebo intravenously every 2 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: 12 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
- Progression Free Survival (PFS)(12 months)
- Objective Response Rate (ORR)(12 months)
- Adverse Events(30 days)
- Time to Progression (TTP)(12 months)
研究者
Shi Ming
Proffessor
Sun Yat-sen University