Ate-Bev Early Response Prediction Model in Advanced HCC

Recruiting

• Conditions: Hepatocellular Carcinoma; Atezolizumab-bevacizumab; Response Evaluation
• Interventions: Diagnostic Test: Early response evaluation

• Registration Number: NCT05763277
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-22
• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ate-Bev	Early response evaluation	Individuals diagnosed with advanced hepatocellular carcinoma and treated with atezolizumab-bevacizumab between the ages of 18-80 were included. According to the recommendations of the American Society of Clinical Oncology-Friends of Cancer Research Organ Dysfunction, patients with comorbidities were excluded.

Primary Outcome Measures

Name	Time	Method
progression free survival	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 Outcome Measures

Name	Time	Method
Overall survival	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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of