RecruitingNot ApplicableNCT05984511

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

TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT: A Phase III, Randomized Clinical Trial


Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Enrollment

234 participants

Start Date

Aug 30, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination approach for liver cancer (hepatocellular carcinoma, or HCC) with a specific type of tumor blood vessel invasion (portal vein tumor thrombus). The combination includes chemoembolization (TACE), immunotherapy (atezolizumab), targeted therapy (bevacizumab), and radioactive seed implants (I-125 brachytherapy). **You may be eligible if:** - You are 18–75 years old with a confirmed diagnosis of liver cancer (HCC) - Your cancer involves a portal vein tumor thrombus of Type I or II - Your liver function is adequate (Child-Pugh class A) - Your overall health is good (ECOG score 0–1) - You have not previously received systemic treatment for HCC **You may NOT be eligible if:** - Your liver cancer is diffuse (spread throughout the entire liver) or has spread outside the liver - You have bleeding disorders or uncontrolled esophageal/stomach varices - You have a history of organ transplant - You are pregnant or breastfeeding - You have a history of autoimmune disease or immune deficiency Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREI-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.

PROCEDURETranscatheter arterial chemoembolization

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

DRUGAtezolizumab plus Bevacizumab

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


Locations(1)

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangzhou, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05984511


Related Trials