TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT

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).

Conditions

• Hepatocellular Carcinoma
• Hepatic Portal Vein Tumor Invasion
• Tumor Thrombus

Interventions

PROCEDURE

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.

PROCEDURE

Transcatheter arterial chemoembolization

TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE).

DRUG

Atezolizumab plus Bevacizumab

Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) .

Sponsors & Collaborators

• Sun Yat-sen University Cancer Center (SUSUCC)

  collaborator UNKNOWN

• Fifth Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Second Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Maoming People's Hospital

  collaborator OTHER

• Shandong Province Third hospital

  collaborator OTHER

• Third Affiliated Hospital, Sun Yat-Sen University

  lead OTHER

Principal Investigators

• Mingsheng Huang, M.D. & Ph.D. · Department of Interventional Radiology, The Third Affiliated Hospital of Sun Yat-sen University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-30

Primary Completion

2028-08-01

Completion

2029-08-01

Countries

• China

Study Locations