dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Intermediate and Advanced Hepatocellular Carcinoma: a Prospective Phase II Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This study intends to evaluate the efficacy and safety of drug-eluting transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (dTACE-HAIC) plus Bevacizumab and Atezolizumab for patients with intermediate-advanced huge hepatocellular carcinoma.
详细描述
Drug-eluting transcatheter arterial embolization (dTACE) and hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin are effective and safe for hepatocellular carcinoma. Atezolizumab + Bevacizumab was superior to sorafenib in overall survival in advanced hepatocellular carcinoma. The anti-VEGF combined programmed cell death protein-1 legend 1 (PD-L1) inhibitor were effective and tolerable in patients with advanced hepatocellular carcinoma. We aimed to describe the efficacy and safety of locoregional therapy (dTACE/HAIC) combined with Bevacizumab and Atezolizumab inhibitor in patients with huge hepatocellular carcinoma who can not receive radical therapy.
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
- •Clinical diagnosis of HCC.
- •Age between 18 and 75 years;
- •The maximum tumor size ≥10 cm;
- •Intermediate-advanced huge HCC, advanced HCC with PVTT type I-III
- •limited metastases (≤5).
- •Child-Pugh class A or B;
- •Eastern Cooperative Group performance status (ECOG) score of 0-1;
- •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
- •Diffuse HCC;
- •Extrahepatic metastasis >5;
- •Obstructive PVTT involving mesenteric vena cava (PVTT IV).
- •Serious medical comorbidities.
- •Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- •untreated or incompletely treated esophageal or gastric varices (assessed with esophagogastroduodenoscopy) with bleeding or high risk of bleeding.
- •Eastern Cooperative Group performance status (ECOG) score of ≥2;
- •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.
结局指标
主要结局
Objective response rate (ORR)
时间窗: 12 months
ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response.
次要结局
- Overall survival (OS)(24 months)
- Progression-Free-Survival (PFS)(12 months)
研究者
Zhou Qunfang
Clinical Professor
Sun Yat-sen University