TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThird Affiliated Hospital, Sun Yat-Sen University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
I-125 Seeds Brachytherapy in PVTT
Procedure/SurgeryIodine125 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
Procedure/SurgeryTACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE).
Atezolizumab plus Bevacizumab
DrugAtezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) .
Treatment groups
234 Participants
are divided into 2 treatment groupsGroup A: TACE plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy (TACE-AB-I)Experimental treatment 3 interventions
Group B: TACE and Atezolizumab/Bevacizumab (TACE-AB)Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
Overall survival (OS)
Time from randomization to death from any cause.
Time frame
2 yearsSecondary outcomes
1
Progression free survival (PFS)
Time from randomization to disease progression (mRECIST) or death from any cause, whichever occurred first.
Time frame
2 years2
Objective response rate (ORR)
The percentage of patients who had a best overall tumor response rating of CR and PR (mRECIST).
Time frame
2 years3
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 years4
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Third Affiliated Hospital, Sun Yat-Sen University
Lead sponsor
Sun Yat-Sen University Cancer Center
Collaborator
Fifth Affiliated Hospital, Sun Yat-Sen University
Collaborator
Second Affiliated Hospital of Guangzhou Medical University
Collaborator
Maoming People's Hospital
Collaborator
Shandong Province Third hospital
Collaborator
Source ClinicalTrials.gov