Atezolizumab and Bevacizumab With Combined Radiotherapy for Advanced Hepatocellular Carcinoma

NCT ID: NCT05908916

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2026-07-31

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Therapeutic arm

AtezoBev with combined radiotherapy

Group Type: EXPERIMENTAL

AtezoBev with combined radiotherapy

Intervention Type: 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.

Interventions

AtezoBev with combined radiotherapy

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. age ≥19;

2. clinically or histologically diagnosed HCC;

3. HCC with Vp2-Vp4 portal vein invasion;

4. intact liver function with Child-Pugh class A;

5. adequate size of RT field;

6. intact performance with ECOG below 2;

7. non-pregnant with acceptable contraception in premenopausal women);

8. without other life-threatening diseases;

9. ability to provide written informed consent and to comply with all study conditions.

Exclusion Criteria

1. Active uncontrolled infection;

2. Current or history (< or = 5 years) of advanced malignancies in the other organs;

3. History of liver transplantation;

4. miliary HCC which incompatible external beam RT

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Do Young Kim

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

Severance hospital

Seoul, , South Korea

Countries

South Korea

Central Contacts

Do Young Kim

Role: CONTACT

dyk1025@yuhs.ac

82-2-2228-1992

Facility Contacts

Do Young Kim

Role: primary

dyk1025@yuhs.ac

82-2-2228-1992

Other Identifiers

4-2023-0384

Identifier Type: -

Identifier Source: org_study_id