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Trial Title:
TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT
NCT ID:
NCT05984511
Condition:
Hepatocellular Carcinoma
Hepatic Portal Vein Tumor Invasion
Tumor Thrombus
Conditions: Official terms:
Carcinoma, Hepatocellular
Bevacizumab
Atezolizumab
Antibodies, Monoclonal
Conditions: Keywords:
Hepatocellular Carcinoma (HCC)
Portal vein tumor thrombosis (PVTT)
Transcatheter arterial chemoembolization (TACE)
I-125 Seeds Brachytherapy
Atezolizumab plus Bevacizumab
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This is a multicenter, open-label trial, randomized controlled trial to evaluate the
efficacy and safety of TACE-AB-I compared with TACE-AB for the treatment of HCC with
branch PVTT.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
I-125 Seeds Brachytherapy in PVTT
Description:
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.
Arm group label:
TACE plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy (TACE-AB-I)
Other name:
Iodine-125 Seeds Implantation
Intervention type:
Procedure
Intervention name:
Transcatheter arterial chemoembolization
Description:
TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE).
Arm group label:
TACE and Atezolizumab/Bevacizumab (TACE-AB)
Arm group label:
TACE plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy (TACE-AB-I)
Other name:
TACE
Intervention type:
Drug
Intervention name:
Atezolizumab plus Bevacizumab
Description:
Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously
every 3 weeks) .
Arm group label:
TACE and Atezolizumab/Bevacizumab (TACE-AB)
Arm group label:
TACE plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy (TACE-AB-I)
Other name:
atezolizumab-bevacizumab; Atez/Bev treatment
Summary:
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).
Detailed description:
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
September 1, 2023
Completion date:
August 1, 2029
Lead sponsor:
Agency:
Third Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Fifth Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
Second Affiliated Hospital of Guangzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Maoming People's Hospital
Agency class:
Other
Collaborator:
Agency:
Shandong Provincial Third Hospital
Agency class:
Other
Source:
Third Affiliated Hospital, Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05984511
