NCT05625893

Proton Beam Radiotherapy Followed by Tecentriq and Avastin for Primary Liver Cancer With Vp2-4 Portal Vein Invasion

Proton Beam Radiotherapy Followed by Tecentriq and Avastin for Primary Liver Cancer With Vp2-4 Portal Vein Invasion: PORTAL Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study is investigator initiated, single-institution, prospective, phase 2 open-label study to determine the efficacy and safety of combination therapy of atezolizumab/bevacizumab and proton beam therapy to portal vein tumor thrombosis with or without main primary tumor in patients with stage 3 or higher hepatocellular carcinoma (HCC) with Vp2-4 portal vein invasion who had not undergone systemic therapy for HCC. The primary endpoint of this study is progression-free survival and secondary endpoints are overall survival (OS), time to progression (TTP), objective response rate, disease control rate (DCR), and time to local disease progression (LTP).

Conditions

• Hepatocellular Carcinoma
• Portal Vein Thrombosis

Interventions

Type	Name	Description
RADIATION	PBT and atezolizumab/bevacizumab	Atezolizumab 1200 mg and bevacizumab 15 mg/Kg is administered IV infusion every 3 weeks. Proton beam therapy 30 - 50 Gy/5 fractions to portal vein tumor thrombosis with or without main primary tumor after 1 week (+/- 7 days) of 2nd cycle of atezolizumab and bevacizumab The follow-up phase begins when the decision to discontinue study is made. The follow-up phase is defined as the day after the end of study treatment until the day the subject dies.

Timeline

• Start date: 2023-01-15
• Primary completion: 2025-11-01
• Completion: 2026-11-01
• First posted: 2022-11-23
• Last updated: 2024-11-29

Locations

1 site across 1 country: South Korea