NCT05984511

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for not_applicable hepatocellular-carcinoma

Timeline
39mo left

Started Aug 2023

Longer than P75 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress45%
Aug 2023Aug 2029

First Submitted

Initial submission to the registry

July 26, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 9, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

August 30, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

4.9 years

First QC Date

July 26, 2023

Last Update Submit

February 7, 2025

Conditions

Hepatocellular CarcinomaHepatic Portal Vein Tumor InvasionTumor Thrombus

Keywords

Hepatocellular Carcinoma (HCC)Portal vein tumor thrombosis (PVTT)Transcatheter arterial chemoembolization (TACE)I-125 Seeds BrachytherapyAtezolizumab plus Bevacizumab

Outcome Measures

Primary Outcomes (1)

  • Overall survival (OS)

    Time from randomization to death from any cause.

    2 years

Secondary Outcomes (4)

  • Progression free survival (PFS)

    2 years

  • Objective response rate (ORR)

    2 years

  • Duration of portal patency

    2 years

  • Adverse events (AEs)

    2 years

Study Arms (2)

TACE plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy (TACE-AB-I)

EXPERIMENTAL

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.

Procedure: I-125 Seeds Brachytherapy in PVTTProcedure: Transcatheter arterial chemoembolizationDrug: Atezolizumab plus Bevacizumab

TACE and Atezolizumab/Bevacizumab (TACE-AB)

ACTIVE COMPARATOR

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.

Procedure: Transcatheter arterial chemoembolizationDrug: Atezolizumab plus Bevacizumab

Interventions

I-125 Seeds Brachytherapy in PVTTPROCEDURE

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.

Also known as: Iodine-125 Seeds Implantation
TACE plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy (TACE-AB-I)
Transcatheter arterial chemoembolizationPROCEDURE

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

Also known as: TACE
TACE and Atezolizumab/Bevacizumab (TACE-AB)TACE plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy (TACE-AB-I)
Atezolizumab plus BevacizumabDRUG

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

Also known as: atezolizumab-bevacizumab; Atez/Bev treatment
TACE and Atezolizumab/Bevacizumab (TACE-AB)TACE plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy (TACE-AB-I)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangzhou, 510630, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

atezolizumabBevacizumab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Mingsheng Huang, M.D. & Ph.D.

    Department of Interventional Radiology, The Third Affiliated Hospital of Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+86-02085253416huangmsh@mail.sysu.edu.cn

Luwen Mu, M.D.

CONTACT

+86-13660534361mulw@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a multicenter, open-label trial, randomized controlled trial to evaluate the efficacy and safety of TACE-AB-I compared with TACE-AB for the treatment of HCC with branch PVTT.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The director of Department of Interventional Radiology

Study Record Dates

First Submitted

July 26, 2023

First Posted

August 9, 2023

Study Start

August 30, 2023

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2029

Last Updated

February 11, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Plan to share IPD with collaborators.

Locations

CN(1)