RecruitingPhase 2NCT04522544

Durvalumab and Tremelimumab in Combination With Y-90 SIRT for Intermediate Stage HCC

A Phase II Study of Immunotherapy With Durvalumab (MEDI4736) and Tremelimumab in Combination With Y-90 SIRT for Intermediate Stage HCC


Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Enrollment

55 participants

Start Date

Dec 15, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

A Phase II study of immunotherapy with Durvalumab (MEDI4736) and Tremelimumab in combination with Y-90 SIRT for intermediate stage HCC


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining two immunotherapy drugs (durvalumab and tremelimumab) with a liver-targeted radiation treatment (Y-90 SIRT, where tiny radioactive beads are injected into blood vessels feeding the tumor) can improve outcomes for people with intermediate-stage liver cancer. **You may be eligible if...** - You are 18 or older and weigh more than 30 kg - You have liver cancer (hepatocellular carcinoma) that has multiple nodules or is a large single tumor, and cannot be removed surgically - Your liver function is relatively preserved (Child-Pugh A) - You have not yet received systemic (whole-body) treatment for liver cancer **You may NOT be eligible if...** - Your cancer has spread beyond the liver to other organs - You have autoimmune diseases that require treatment - Your liver function is severely compromised 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

DRUGTremelimumab

300 mg Tremelimumab C1D1

DRUGDurvalumab

1500 mg Durvalumab C1D1 + Q4W (max. 13 cycles)

PROCEDUREY-90 SIRT

Locoregional therapy will be performed as a standard-of-care procedure

PROCEDUREDEB-TACE

Locoregional therapy will be performed as a standard-of-care procedure


Locations(12)

Universitätsklinikum Bonn

Bonn, Germany

Universitätsklinikum Köln

Cologne, Germany

Universitätsklinikum Essen

Essen, Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Universitätsmedizin Göttingen

Göttingen, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Universitätsklinikum Jena

Jena, Germany

Universtitätsklinikum Schleswig-Holstein

Lübeck, Germany

Klinikum rechts der Isar der Technischen Universität München

München, Germany

München Klinik Bogenhausen

München, Germany

Universitätsklinikum Münster

Münster, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

View Full Details on ClinicalTrials.gov

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NCT04522544


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