TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT: A Phase III, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The present study aimed to assess the effectiveness of the combination treatment of Atezolizumab/Bevacizumab, transcatheter arterial chemoembolization (TACE) and I-125 Seeds Brachytherapy (TACE-AB-I) in patients with advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT). The investigators confirmed that the combination therapy yielded better survival data than the combined administration of Atezolizumab/Bevacizumab and TACE (TACE-AB) in patients with advanced HCC and Type I/II PVTT (Based on Cheng's PVTT classification).
详细描述
This is a multicenter, open-label trial, randomized controlled to evaluate the efficacy and safety of TACE-AB-I compared with TACE-AB for the treatment of HCC with branch PVTT. 234 HCC patients with branch PVTT will be enrolled in this study. The Patients will be treated with TACE-AB-I or TACE-AB using a 1:1 randomization scheme. TACE will be performed for the patients after randomization. Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) will be started at 3-7 days after the first TACE and I-125 Seeds Brachytherapy and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. For patients in the TACE-AB-I arm, iodion-125 seeds will be implanted into the PVTT (according to the pre-operative planning) under CT guidance within 3-7 days after the first TACE. TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.
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
- 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
- •Age between18 and 75 years;
- •Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- •Type I PVTT or type II PVTT;
- •Child-Pugh class A;
- •Eastern Cooperative Group performance status (ECOG) score of 0-1;
- •No prior systemic therapy for HCC.
- •Adequate hematologic and end-organ function;
- •At least one measurable intrahepatic target lesion.
排除标准
- •Diffuse HCC;
- •Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes (confirmed by histology, or pathology) are not eligible;
- •Evidence of extrahepatic spread (EHS);
- •Any condition representing a contraindication to TACE or I-125 seeds brachytherapy as determined by the investigators;
- •Evidence or history of bleeding diathesis or any hemorrhage or bleeding event >CTCAE grade 3 within 4 weeks prior to randomization;
- •Active or history of autoimmune disease or immune deficiency;
- •Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk for bleeding;
- •A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment;
- •Evidence of bleeding diathesis or significant coagulopathy;
- •Pregnant or breastfeeding females;
- •Significant cardiovascular disease;
- •Severe infection, such as active tuberculosis;
- •Serious medical comorbidities;
- •History of organ or cells transplantation;
- •History of other uncurable malignancies.
研究组 & 干预措施
TACE plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy (TACE-AB-I)
TACE will be performed for the patients after randomization. Iodion-125 seeds will be implanted into the PVTT under CT guidance within 3-7 days after the first TACE.
Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) will be started at 3-7 days after the first TACE and I-125 Seeds Brachytherapy.
TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.
干预措施: I-125 Seeds Brachytherapy in PVTT (Procedure)
TACE plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy (TACE-AB-I)
TACE will be performed for the patients after randomization. Iodion-125 seeds will be implanted into the PVTT under CT guidance within 3-7 days after the first TACE.
Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) will be started at 3-7 days after the first TACE and I-125 Seeds Brachytherapy.
TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.
干预措施: Transcatheter arterial chemoembolization (Procedure)
TACE plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy (TACE-AB-I)
TACE will be performed for the patients after randomization. Iodion-125 seeds will be implanted into the PVTT under CT guidance within 3-7 days after the first TACE.
Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) will be started at 3-7 days after the first TACE and I-125 Seeds Brachytherapy.
TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.
干预措施: Atezolizumab plus Bevacizumab (Drug)
TACE and Atezolizumab/Bevacizumab (TACE-AB)
TACE will be performed for the patients after randomization. Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) will be started at 3-7 days after the first TACE.
TACE can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.
干预措施: Transcatheter arterial chemoembolization (Procedure)
TACE and Atezolizumab/Bevacizumab (TACE-AB)
TACE will be performed for the patients after randomization. Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) will be started at 3-7 days after the first TACE.
TACE can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.
干预措施: Atezolizumab plus Bevacizumab (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: 2 years
Time from randomization to death from any cause.
次要结局
- Progression free survival (PFS)(2 years)
- Objective response rate (ORR)(2 years)
- Duration of portal patency(2 years)
- Adverse events (AEs)(2 years)
研究者
Huang Mingsheng
The director of Department of Interventional Radiology
Third Affiliated Hospital, Sun Yat-Sen University