Actively Recruiting
Durvalumab and Tremelimumab in Combination With Y-90 SIRT for Intermediate Stage HCC
Led by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Updated on 2026-02-18
55
Participants Needed
12
Research Sites
367 weeks
Total Duration
On this page
Sponsors
I
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Phase II study of immunotherapy with Durvalumab (MEDI4736) and Tremelimumab in combination with Y-90 SIRT for intermediate stage HCC
CONDITIONS
Official Title
Durvalumab and Tremelimumab in Combination With Y-90 SIRT for Intermediate Stage HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent before any study procedures
- Age 18 years or older at study entry
- Body weight greater than 30 kg
- Diagnosed with multinodular or large solitary hepatocellular carcinoma not suitable for surgery or local ablation
- Histologically confirmed hepatocellular carcinoma diagnosis
- Scheduled to receive locoregional therapy as standard care
- At least one measurable tumor site by CT scan or MRI using RECIST 1.1 criteria
- No prior systemic anti-cancer treatments
- Child-Pugh liver function class A
- Performance status of 0 or 1 on the ECOG scale
- Life expectancy of at least 12 weeks
- Adequate blood counts, liver enzyme levels, and kidney function as defined by specific laboratory thresholds
- Albumin levels of 31 g/dL or higher
- Creatinine clearance greater than 40 mL/min by standard calculation methods
- Female patients of childbearing potential must have a negative pregnancy test within 7 days before starting and use two effective contraception methods if sexually active
- Men sexually active with women of childbearing potential must use contraception with less than 1% failure rate; contraception advised for 7 months after last dose
- Patients with controlled hepatitis B or C infection under specified monitoring and treatment conditions
- Willing and able to follow the study protocol for its entire duration
You will not qualify if you...
- Diffuse hepatocellular carcinoma or cancer spreading beyond the liver except limited invasion of certain veins
- Advanced liver disease classified as Child-Pugh B or C
- Contraindications to liver embolization procedures such as abnormal blood flow, blood clotting issues, or severe artery disease
- Kidney failure requiring dialysis
- Locoregional therapies ongoing or completed less than 4 weeks before baseline scan
- History of significant heart disease including heart failure beyond NYHA class 2, uncontrolled arrhythmias, or uncontrolled high blood pressure
- Recent major gastrointestinal bleeding within 4 weeks before starting study drug
- Recent thrombotic or embolic events within 6 months before first dose except limited portal vein thrombosis
- Prior systemic anti-cancer therapy, radiotherapy, endocrine or immunotherapy, or investigational agents within defined timelines
- Use of immunosuppressive medication within 14 days before first study drug dose with certain exceptions
- Receipt of live attenuated vaccine within 30 days before first dose
- Major surgery within 4 weeks before study start without full recovery
- Second primary cancer unless treated and disease-free for at least 3 years
- Any medical condition increasing risk during study participation
- Uncontrolled infections or illnesses that limit compliance or increase risk
- Active tuberculosis or hepatitis B surface antigen positive without control
- History of organ transplantation
- Psychiatric disorders preventing informed consent or compliance
- Symptomatic brain metastases
- Pregnant or breastfeeding women
- Immunocompromised patients including known HIV positive
- Active or prior autoimmune or inflammatory disorders with specific exceptions
- Known allergy to study drugs or their components
- Participation in another investigational study or device use within 4 weeks prior to first dose
- History of incarceration or involuntary detention
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 12 locations
1
Universitätsklinikum Bonn
Bonn, Germany, 53127
Actively Recruiting
2
Universitätsklinikum Köln
Cologne, Germany, 50937
Actively Recruiting
3
Universitätsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
4
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany, 79106
Withdrawn
5
Universitätsmedizin Göttingen
Göttingen, Germany, 37075
Actively Recruiting
6
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
7
Universitätsklinikum Jena
Jena, Germany, 07747
Actively Recruiting
8
Universtitätsklinikum Schleswig-Holstein
Lübeck, Germany, 23538
Actively Recruiting
9
Klinikum rechts der Isar der Technischen Universität München
München, Germany, 81675
Actively Recruiting
10
München Klinik Bogenhausen
München, Germany, 81925
Actively Recruiting
11
Universitätsklinikum Münster
Münster, Germany, 48149
Actively Recruiting
12
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Actively Recruiting
Research Team
A
Arndt Vogel, Prof. Dr.
CONTACT
J
Johanna Riedel, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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