Ate-Bev Early Response Prediction Model in Advanced HCC

NCT ID: NCT05763277

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 170 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-22
• Study Completion Date: 2026-12-31

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.

Conditions

Hepatocellular Carcinoma; Atezolizumab-bevacizumab; Response Evaluation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Ate-Bev

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.

Early response evaluation

Intervention Type: 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).

Interventions

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).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeong-Hoon Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jeong-Hoon Lee, MD PhD

Role: CONTACT

pindra@empal.com

+82-2-2072-2228

Hyunjae Shin, MD

Role: CONTACT

yhstella@gmail.com

+82-2-2072-2228

Facility Contacts

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

Role: primary

pindra@empal.com

Other Identifiers

2206-066-1332

Identifier Type: -

Identifier Source: org_study_id