RecruitingPhase 2NCT05625893

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


Sponsor

Samsung Medical Center

Enrollment

63 participants

Start Date

Jan 15, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of proton beam radiation therapy followed by two immunotherapy/anti-angiogenesis drugs (atezolizumab and bevacizumab, sold as Tecentriq and Avastin) for primary liver cancer (hepatocellular carcinoma) that has grown into the portal vein — one of the main vessels supplying the liver. **You may be eligible if...** - You are 20 or older with confirmed liver cancer (hepatocellular carcinoma) - Your cancer has grown into the portal vein (a specific blood vessel in the liver, graded Vp2–4) - You have at least one measurable liver tumor - Your liver function is reasonably preserved (Child-Pugh class A) - Your performance status is good (ECOG 0–1) - Your blood counts, liver, and kidney tests meet minimum thresholds **You may NOT be eligible if...** - Your liver function is significantly impaired (Child-Pugh B or C) - You have active, uncontrolled hepatitis B or C - You have active autoimmune disease or a history of organ transplantation - You have serious heart problems or uncontrolled bleeding risk - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONPBT 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.


Locations(1)

Samsung Medical Center

Seoul, South Korea

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NCT05625893


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