An interventional study of I-125 Seeds Brachytherapy in PVTT and Transcatheter arterial chemoembolization in Hepatocellular Carcinoma, Hepatic Portal Vein Tumor Invasion and Tumor Thrombus, sponsored by Third Affiliated Hospital, Sun Yat-Sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-11.
Sponsored by Third Affiliated Hospital, Sun Yat-Sen University · Not applicable, Interventional, and Treatment
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).
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.
3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.
This study's planned enrollment of 234 is above the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Third Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 130 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
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.
Procedure: I-125 Seeds Brachytherapy in PVTT · Procedure: Transcatheter arterial chemoembolization · Drug: Atezolizumab plus Bevacizumab
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.
Procedure: Transcatheter arterial chemoembolization · Drug: Atezolizumab plus Bevacizumab
Iodine125 seed implantation into the PVTT was conducted 3-7 days after TACE when the results of the liver function tests were comparable to those obtained before TACE. Pre-procedural planning was conducted using a three-dimensional conformal radiation therapy treatment planning system (TPS) to determine the number of Iodine125 seeds required, the target location for implantation, the best percutaneous puncture site and the access route. The targeted zone for implantation was the tumour thrombosis in the segmental portal vein, left/right portal vein. Implantation was guided by CT, and the Iodine125 seeds were implanted into the PVTT using 18 G needles and the implantation gun that housed the Iodine125 seeds in the cartridge chamber.
Also known as: Iodine-125 Seeds Implantation
TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE).
Also known as: TACE
Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) .
Also known as: atezolizumab-bevacizumab; Atez/Bev treatment
Overall survival (OS)
Time from randomization to death from any cause.
Time frame: 2 years
Progression free survival (PFS)
Time from randomization to disease progression (mRECIST) or death from any cause, whichever occurred first.
Time frame: 2 years
Objective response rate (ORR)
The percentage of patients who had a best overall tumor response rating of CR and PR (mRECIST).
Time frame: 2 years
Duration of portal patency
The time from randomization until the date that complete portal vein occlusion was confirmed (if the portal vein is patent at diagnosis).
Time frame: 2 years
Adverse events (AEs)
Number of patients with AE, treatment-related AE (TRAE), AE of special interest (AESI), serious adverse event (SAE), assessed by NCI CTCAE v5.0.
Time frame: 2 years
Plan to share: No — Plan to share IPD with collaborators.
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Third Affiliated Hospital, Sun Yat-Sen University