Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05984511

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

Led by Third Affiliated Hospital, Sun Yat-Sen University · Updated on 2025-02-11

234

Participants Needed

1

Research Sites

309 weeks

Total Duration

On this page

Sponsors

T

Third Affiliated Hospital, Sun Yat-Sen University

Lead Sponsor

S

Sun Yat-Sen University Cancer Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between18 and 75 years
  • Diagnosis of hepatocellular carcinoma confirmed by radiology, histology, or cytology
  • Presence of type I or type II portal vein tumor thrombosis (PVTT)
  • Child-Pugh class A liver function
  • Eastern Cooperative Group performance status (ECOG) score of 0-1
  • No prior systemic therapy for hepatocellular carcinoma
  • Adequate blood counts and organ function
  • At least one measurable tumor lesion in the liver
Not Eligible

You will not qualify if you...

  • Diffuse hepatocellular carcinoma
  • Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, or mixed hepatocellular/cholangiocarcinoma subtypes
  • Evidence of cancer spread outside the liver
  • Any condition that prevents TACE or I-125 seeds brachytherapy as assessed by investigators
  • History or evidence of significant bleeding or bleeding disorders within 4 weeks before randomization
  • Active or past autoimmune disease or immune deficiency
  • Untreated or high-risk esophageal or gastric varices for bleeding
  • Bleeding from esophageal or gastric varices within 6 months before study treatment
  • Significant blood clotting problems
  • Pregnant or breastfeeding women
  • Serious heart disease
  • Severe infections like active tuberculosis
  • Serious other medical conditions
  • History of organ or cell transplantation
  • History of other incurable cancers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangzhou, China, 510630

Actively Recruiting

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Research Team

M

Mingsheng Huang, M.D. & Ph.D.

CONTACT

L

Luwen Mu, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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