A single-arm phase II trial of Atezolizumab and Bevacizumab with combined radiotherapy in advanced hepatocellular carcinoma with portal vein invasion

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0008733

Enrollment

Registered

2023-08-23

Start date

2023-09-01

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug, Radiation : Intervention description: Atezolizumab (1200mg) and Bevacizumab (15mg/kg) are administered to patients once for each cycle with 3-week intervals, and additional radiotherapy (iGTV 50

Eligibility

Sex/Gender

All

Inclusion 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) adequate liver function ; AST/ALT =5 times the upper limits of normal) ; no coagulopathy (7) intact performance with ECOG below 2 (8) non-pregnant with acceptable contraception in premenopausal women) (9) without other life-threatening diseases (10) ability to provide written informed consent and to comply with all study conditions.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
Overall survival;Objective response rate;Safety and adverse event	—

Countries

Korea, Republic of

Contacts

Public ContactJae Seung Lee

Yonsei University Health System, Severance Hospital

sikarue@yuhs.ac+82-2-2228-2286

Outcome results