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TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT

RecruitingNAAges 18 Years - 75 YearsAllThird Affiliated Hospital, Sun Yat-Sen University
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • I-125 Seeds Brachytherapy in PVTT
  • Transcatheter arterial chemoembolization
  • Atezolizumab plus Bevacizumab
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Where

1 site
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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