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NCT Number: NCT05763277

Ate-Bev Early Response Prediction Model in Advanced HCC

The prognosis of hepatocellular carcinoma is poor compared to other carcinomas. Many drugs have recently been developed, and recently, atezolizumab-bevacizumab treatment was superior to sorafenib, the conventional treatment for advanced hepatocellular carcinoma. However, there is no information on the evaluation on the evaluation of treatment response for atezolizumab-bevacizumab combination therapy compared to atezolizumab alone or bevacizumab alone. Therefore, this study aimed to create a predictive model that can detect treatment response at an early stage.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Atezolizumab-bevacizumab 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 Response Evaluation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Jeong-Hoon Lee, M.D., Ph.D.

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients who were diagnosed with advanced hepatocellular carcinoma and who were scheduled to receive atezolizumab-bevacizumab as the first-line therapy
  • Patients willing to participate in this study

Exclusion criteria

  • Individuals with a history of severe contrast allergy
  • Individuals with severe comorbidities (according to the American Society of Clinical Oncology-Friends of Cancer Research Organ Dysfunction.)

Treatment and study plan

Early response evaluation

Diagnostic Test

Atezolizumab and bevacizumab are administered every three weeks, and before to the second treatment cycle, blood tests and imaging tests are conducted (week 5). This precedes the standard response evaluation (week 9-12).

Primary outcomes

  1. progression free survival

    Time frame: the follow up will be continued until June 22th 2025.

    the index date is the date of treatment with atezolizumab and bevacizumab, and the event is either death or tumor progression of the tumor.

Secondary outcomes

  1. Overall survival

    Time frame: the follow up will be continued until June 22th 2025.

    the index date is the date of treatment with atezolizumab and bevacizumab, and the event is death.

Study contacts

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

Hyunjae Shin, MD

CONTACT

[email protected]

+82-2-2072-2228

Jeong-Hoon Lee, MD PhD

CONTACT

[email protected]

+82-2-2072-2228

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Developing Atezolizumab-Bevacizumab Treatment Response Early Prediction Model in Advanced Hepatocellular Carcinoma Patients

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Mar 10, 2023
Registry last updated
May 15, 2025

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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