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RECRUITINGPHASE2

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

NCT05625893•Samsung Medical Center

View on ClinicalTrials.gov

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

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with HCC meeting all of following criteria;
•1. Histologically or radiologically confirmed hepatocellular carcinoma based on the guidelines of the Korean Liver Cancer Association-National Cancer Center 2022
•2. Age \>= 20
•3. Vp2-4 portal vein tumor thrombosis diagnosed by dynamic enhanced computed tomography (CT) or maganetic resonance images (MRI) with below finding 1) an intraluminal filling defect adjacent to the primary tumor in Vp2-4 portal vein 2) an enhancement of the filling defect on arterial phase and a washout on portal/delayed phases.
•4. Signed written informed consent
•5. at least one or more measurable intrahepatic viable HCC lesions
•6. Child-Pugh class A within 2 weeks from screening for study registration
•7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 within 2 weeks from screening for study registration
•8. Life expectancy of at least 16 weeks
•9. adequate bone marrow and liver function within 2 weeks from screening for study registration
+9 more criteria

Exclusion Criteria

•13. no limitation according to the size and number of tumors in the liver.
•Patients with HCC meeting all of following criteria;
•1. previous history of systemic treatment for HCC (If systemic treatment for HCC has been performed at least once, it will not be enrolled in this study.) However, registration is permitted if the previous systemic treatment is for adjuvant purposes or treatment for other cancers. Also allowed if previous HCC treatment is local treatment. However, cases with a history of previous upper abdominal radiotherapy (including proton therapy and heavy particle therapy) are excluded.
•2. any type of anticancer agent (including investigational) within 2 weeks before enrollment
•3. Having active brain metastasis or leptomeningeal metastasis need surgery or steroid therapy
•4. Moderate to severe or intractable ascites
•5. A history or presence of hepatic encephalopathy
•6. Presence of active bacterial infection
•7. Untreated active chronic hepatitis B or active hepatitis C
•8. History of portal hypertension with bleeding within the past 6 months
+9 more criteria

Locations (1)

Samsung Medical Center

Seoul, South Korea

Key Dates

Start Date

January 15, 2023

Primary Completion Date

November 1, 2025

Completion Date

November 1, 2026

Last Updated

November 29, 2024

Enrollment

ESTIMATED participants

Conditions

Hepatocellular CarcinomaPortal Vein Thrombosis

Interventions

PBT and atezolizumab/bevacizumab

RADIATION

Contacts

Jeong Il Yu, MD, PhD

CONTACT

82-2-3410-9598 ro.yuji651@gmail.com

Early Detection of Liver Cancer by QUS

NCT06345508

Hepatocellular CarcinomaLiver Cancer

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Renal Cell Carcinoma (Kidney Cancer)Non Small Cell Lung Cancer+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 29, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Early Detection of Liver Cancer by QUS

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

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