TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT
Hepatocellular Carcinoma, Hepatic Portal Vein Tumor Invasion, Tumor Thrombus
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma (HCC), Portal vein tumor thrombosis (PVTT), Transcatheter arterial chemoembolization (TACE), I-125 Seeds Brachytherapy, Atezolizumab plus Bevacizumab
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
TACE plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy (TACE-AB-I)
TACE and Atezolizumab/Bevacizumab (TACE-AB)
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.
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.