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NCT Number: NCT05908916

Atezolizumab and Bevacizumab With Combined Radiotherapy for Advanced Hepatocellular Carcinoma

Atezolizumab plus Bevacizumab combination therapy (AtezoBev) is well-known 1st-line therapy for advanced hepatocellular carcinoma (HCC). However, there are unmet needs for patients with advanced HCC who do not respond to AtezoBev. External beam radiotherapy (RT) is another well-known locoregional therapy for HCC that induces inflammatory cascade and abscopal effect as a systemic anticancer effect and enhances the effect of AtezoBev. Therefore, the investigators aim to verify the effect of AtezoBev plus RT for advanced HCC through this single-center, prospective phase II one-armed cohort study over three years. This study recruits 51 patients to verify the effect of the intervention. Atezolizumab (1200mg) and Bevacizumab (15mg/kg) are administered to patients once for each cycle at 3-week intervals, and additional radiotherapy for the mass or portal vein tumor thrombosis is performed before second cycle of AtezoBev. The primary endpoint is progression-free survival by using response evaluation with modified RECIST.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥19;
  • clinically or histologically diagnosed HCC;
  • HCC with Vp2-Vp4 portal vein invasion;
  • intact liver function with Child-Pugh class A;
  • adequate size of RT field;
  • intact performance with ECOG below 2;
  • non-pregnant with acceptable contraception in premenopausal women);
  • without other life-threatening diseases;
  • ability to provide written informed consent and to comply with all study conditions.

Exclusion criteria

  • Active uncontrolled infection;
  • Current or history (< or = 5 years) of advanced malignancies in the other organs;
  • History of liver transplantation;
  • miliary HCC which incompatible external beam RT

Treatment and study plan

AtezoBev with combined radiotherapy

Drug

Atezolizumab (1200mg) and Bevacizumab (15mg/kg) are administered to patients once for each cycle with 3-week intervals, and additional radiotherapy (iGTV 50-60 Gy, CTV 40Gy, PTV 30Gy / 10Fx) for the mass or portal vein tumor thrombosis is performed before second cycle of AtezoBev.

Primary outcomes

  1. Progression-free survival

    Time frame: 2 years (per 9 weeks)

    Duration between AtezoBev initiation and tumor progression by mRECIST or patient's death

Study contacts

Contact information is provided by the study sponsor or research team.

Do Young Kim

CONTACT

[email protected]

82-2-2228-1992

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

A Single-arm Phase II Trial of Atezolizumab and Bevacizumab With Combined Radiotherapy in Advanced Hepatocellular Carcinoma With Portal Vein Invasion

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 18, 2023
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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