TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT
- Conditions
- Hepatic Portal Vein Tumor InvasionHepatocellular CarcinomaTumor Thrombus
- Interventions
- Procedure: I-125 Seeds Brachytherapy in PVTTProcedure: Transcatheter arterial chemoembolization
- Registration Number
- NCT05984511
- Lead Sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 234
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TACE plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy (TACE-AB-I) Atezolizumab plus Bevacizumab 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. TACE and Atezolizumab/Bevacizumab (TACE-AB) 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. TACE plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy (TACE-AB-I) I-125 Seeds Brachytherapy in PVTT 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. TACE plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy (TACE-AB-I) Transcatheter arterial chemoembolization 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. TACE and Atezolizumab/Bevacizumab (TACE-AB) Transcatheter arterial chemoembolization 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.
- Primary Outcome Measures
Name Time Method Overall survival (OS) 2 years Time from randomization to death from any cause.
- Secondary Outcome Measures
Name Time Method Progression free survival (PFS) 2 years Time from randomization to disease progression (mRECIST) or death from any cause, whichever occurred first.
Objective response rate (ORR) 2 years The percentage of patients who had a best overall tumor response rating of CR and PR (mRECIST).
Duration of portal patency 2 years The time from randomization until the date that complete portal vein occlusion was confirmed (if the portal vein is patent at diagnosis).
Adverse events (AEs) 2 years Number of patients with AE, treatment-related AE (TRAE), AE of special interest (AESI), serious adverse event (SAE), assessed by NCI CTCAE v5.0.
Trial Locations
- Locations (1)
The Third Affiliated Hospital of Sun Yat-Sen University
🇨🇳Guangzhou, Guangzhou, China