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NCT05984511Recruiting

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

Source: ClinicalTrials.gov · Last updated 11 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Interventional
Enrollment
234 (estimated)
First submitted
26 Jul 2023
Start date
30 Aug 2023
Primary completion date
1 Aug 2028
Lead sponsor
Third Affiliated Hospital, Sun Yat-Sen University
NCT number
NCT05984511

What you commit to

  • Study type: Interventional
  • Planned participants: 234
  • From 30 Aug 2023 to the primary completion date, 1 Aug 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Evidence or history of bleeding diathesis or any hemorrhage or bleeding event \>CTCAE grade 3 within 4 weeks prior to randomization;
  • A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment;

Other illness

  • Any condition representing a contraindication to TACE or I-125 seeds brachytherapy as determined by the investigators;
  • 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;
  • Evidence of bleeding diathesis or significant coagulopathy;
  • Significant cardiovascular disease;
  • Severe infection, such as active tuberculosis;
  • History of organ or cells transplantation;
  • History of other uncurable malignancies.

Other

  • 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);
  • Pregnant or breastfeeding females;
  • Serious medical comorbidities;

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
The Third Affiliated Hospital of Sun Yat-Sen University
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.