Atezolizumab and Bevacizumab With Combined Radiotherapy for Advanced Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

A Single-arm Phase II Trial of Atezolizumab and Bevacizumab With Combined Radiotherapy in Advanced Hepatocellular Carcinoma With Portal Vein Invasion

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05908916
• Other study ID #: 4-2023-0384
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2023
• Est. completion date: July 2026

Study information

• Verified date: June 2023
• Source: Yonsei University
• Contact: Do Young Kim
• Phone: 82-2-2228-1992
• Email: dyk1025[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 51
• Est. completion date: July 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	Duration between AtezoBev initiation and tumor progression by mRECIST or patient's death	2 years (per 9 weeks)