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Atezolizumab Plus Bevacizumab Alone or Combined With External Beam Radiotherapy for HCC With Macrovascular Invasion (ALERT-HCC)

5. november 2026 opdateret af: Ju Hyun Shim, Asan Medical Center

A Randomized, Multicenter, Open-Label, Phase II Trial of Atezolizumab Plus Bevacizumab Alone or Combined With External Beam RadioTherapy for HepatoCellular Carcinoma With Macrovascular Invasion (ALERT-HCC)

The recent global IMbrave150 study evaluated the combination of atezolizumab and bevacizumab versus sorafenib in 501 patients with advanced or metastatic Hepatocellular Carcinoma (HCC). The median overall survival (OS) was notably better in the atezolizumab/bevacizumab group. However, for HCC patients with intrahepatic macrovascular invasion (MVI), the prognosis remains poor, indicating a significant unmet need in this group.

External Beam Radiotherapy (EBRT) has shown promising results in treating HCC with MVI, especially when used in combination with trans-arterial chemoembolization (TACE). It has been reported that radiotherapy may make tumor cells more susceptible to immune-mediated therapy, potentially enhancing the effects of atezolizumab and bevacizumab.

Thus, this study aims to investigate the efficacy and safety of atezolizumab/bevacizumab alone versus atezolizumab/bevacizumab in combination with EBRT in HCC patients with macrovascular invasion.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A total of 138 subjects are randomly assigned to one of two treatment groups (69 patients in the atezolizumab+bevacizumab group and 69 patients in the Atezolizumab plus Bevacizumab combined EBRT group).

  • Radiotherapy combination:

    • Atezolizumab will be administered by IV, 1200 mg on day 1 of each 21day cycle.
    • Bevacizumab will be administered by IV, 15 mg/kg on day 1 of each 21day cycle.
    • The external beam radiotherapy will commence after day 2 of the first cycle of Atezolizumab+Bevacizumab, and will be delivered in accordance with institutional protocol.

  • Atezolizumab+Bevacizumab:

    • Atezolizumab will be administered by IV, 1200 mg on day 1 of each 21day cycle.
    • Bevacizumab will be administered by IV, 15 mg/kg on day 1 of each 21day cycle.

Additional study identifiers: This study was also registered on the WHO's International Clinical Trials Registry Platform, CRIS, before the first participant was enrolled (ID: KCT0007365, Date of registration: 2022-06-08).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

138

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Sydkorea
      • Seoul, Sydkorea
        • Asan Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 79 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Older than 19 years of age, lower than 80 years of age

  • Child-Pugh class A hepatic function

  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1

  • Patients with HCC [diagnosed according to AASLD guidelines] invading the intrahepatic vascular system

  • No prior systemic therapy for HCC

  • At least one measurable HCC lesion with ≥ 1cm diameter

  • Adequate hematologic and organ function

    • Hemoglobin ≥ 9.0 g/dL
    • Absolute neutrophil count ≥ 1,000 /mm3
    • Platelet ≥ 50,000/ mm3 without transfusion

  • Total bilirubin ≤ 2.5 mg/dL

Exclusion Criteria:

  • Treatment history of prior systemic treatment of HCC
  • Liver transplant recipients
  • Patients with peptic ulcer, untreated or incompletely treated varices with bleeding or high-risk for bleeding
  • Any serious illness (e.g., active infection or inflammatory condition) or uncontrolled severe medical comorbidity
  • A history of treated malignancy (other than HCC) is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding two years
  • Abdominal/pelvic radiotherapy within 28 days prior to initiation of study treatment, except palliative radiotherapy to bone lesions within 7 days prior to initiation of study treatment

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Radiotherapy combination

Atezolizumab+Bevacizumab, combined EBRT to vascular invasion

  • Atezolizumab will be administered by IV, 1200 mg on day 1 of each 21day cycle.
  • Bevacizumab will be administered by IV, 15 mg/kg on day 1 of each 21day cycle.
  • The external beam radiotherapy will commence after day 2 of the first cycle of A+B, and will be delivered in accordance with institutional protocol.
Stråling: Atezolizumab plus bevacizumab, combined EBRT to vascular invasion

The external beam radiotherapy will commence after day 2 of the first cycle of atezolizumab+bevacizumab, and will be delivered in accordance with institutional protocol.

3D-conformal radiotherapy technique is used to determine target volumes, radiation ports, and dose prescriptions by using a 3D radiotherapy planning system.

The gross tumor volume (GTV) includes vascular invasion and a 2-cm margin into the contiguous HCC. The GTV can consist of the entire HCC and vascular invasion at the discretion of the investigator.

The target dose is 45 Gy, however, the total dose can be reduced as low as 30 Gy according to the liver function, liver volumes, or the maximum dose to the stomach/duodenum during the planning process according to the judgment of the radiation oncologist of each participating sites.
Aktiv komparator: Atezolizumab+Bevacizumab
  • Atezolizumab will be administered by IV, 1200 mg on day 1 of each 21day cycle.
  • Bevacizumab will be administered by IV, 15 mg/kg on day 1 of each 21day cycle.
Medicin: Atezolizumab plus bevacizumab

Atezolizumab plus bevacizumab q3w

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
progression-free survival rate
Tidsramme: up to approximately 3 years

Randomization to the first occurrence of disease progression or death from any cause, whichever occurs first
up to approximately 3 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall survival rate
Tidsramme: up to approximately 3 years

Randomization to death from any cause, through the end of study
up to approximately 3 years
Objective response
Tidsramme: up to approximately 3 years

complete response or partial response as determined by the Investigator according to RECIST V1.1
up to approximately 3 years
Adverse reaction rate
Tidsramme: through study completion, up to approximately 3 years

Adverse reaction rate assessed by CTCAE version 5
through study completion, up to approximately 3 years
Time to deterioration
Tidsramme: through study completion, up to approximately 3 years

The time from randomization to first deterioration (decrease from baseline of ≥10 points) in the patient-reported global health status (GHS) / Quality of life (QoL), physical function, or role function scales of the EORTC QLQ-C30, maintained for two consecutive assessments, or one assessment followed by death from any cause within 3 weeks
through study completion, up to approximately 3 years
Duration of response
Tidsramme: up to approximately 3 years

the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression or death is documented, whichever occurs first. DOR will be assessed in patients who had an objective response.
up to approximately 3 years
Tumor marker response (AFP, PIVKA-II)
Tidsramme: through study completion, up to approximately 3 years

The decrease of >20% in serum concentration of each marker from baseline across all time points during study period.
through study completion, up to approximately 3 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Asan Medical Center

Samarbejdspartnere

Seoul National University Hospital
Soon Chun Hyang University
Hanyang University Guri Hospital

Efterforskere

  • Ledende efterforsker: Ju Hyun Shim, Asan Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. oktober 2022

Primær færdiggørelse (Faktiske)

25. februar 2026

Studieafslutning (Faktiske)

25. februar 2026

Datoer for studieregistrering

Først indsendt

27. juli 2023

Først indsendt, der opfyldte QC-kriterier

7. august 2023

Først opslået (Faktiske)

15. august 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. november 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KCT0007365
  • KCT0007365 (Registry Identifier: CRIS (International Clinical Trials Registry Platform))

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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