TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT
NCT ID: NCT05984511
Last Updated: 2025-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
234 participants
INTERVENTIONAL
2023-08-30
2029-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
I-125 Seeds Brachytherapy in PVTT
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.
Transcatheter arterial chemoembolization
TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE).
Atezolizumab plus Bevacizumab
Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) .
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.
Transcatheter arterial chemoembolization
TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE).
Atezolizumab plus Bevacizumab
Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) .
Interventions
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I-125 Seeds Brachytherapy in PVTT
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.
Transcatheter arterial chemoembolization
TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE).
Atezolizumab plus Bevacizumab
Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) .
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University Cancer Center (SUSUCC)
UNKNOWN
Fifth Affiliated Hospital, Sun Yat-Sen University
OTHER
Second Affiliated Hospital of Guangzhou Medical University
OTHER
Maoming People's Hospital
OTHER
Shandong Province Third hospital
OTHER
Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
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Huang Mingsheng
The director of Department of Interventional Radiology
Principal Investigators
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Mingsheng Huang, M.D. & Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Interventional Radiology, The Third Affiliated Hospital of Sun Yat-sen University
Locations
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The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangzhou, China
Countries
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Central Contacts
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Facility Contacts
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Mingsheng Huang
Role: primary
Other Identifiers
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II2023-162-02
Identifier Type: -
Identifier Source: org_study_id
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