Ate-Bev Early Response Prediction Model in Advanced HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05763277
• Other study ID #: 2206-066-1332
• Status: Recruiting
• Start date: July 22, 2022
• Est. completion date: May 22, 2025

Study information

• Verified date: April 2024
• Source: Seoul National University Hospital
• Contact: Jeong-Hoon Lee, MD PhD
• Phone: +82-2-2072-2228
• Email: pindra[@]empal.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: May 22, 2025
• Est. primary completion date: May 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Diagnostic Test:
• Early response evaluation
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).

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival	the index date is the date of treatment with atezolizumab and bevacizumab, and the event is either death or tumor progression of the tumor.	the follow up will be continued until June 22th 2025.
Secondary	Overall survival	the index date is the date of treatment with atezolizumab and bevacizumab, and the event is death.	the follow up will be continued until June 22th 2025.