2024-515127-11-00RecruitingPhase 2
Study on the effect of 2 immunotherapy drugs in combination with radioactive glass spheres on the survival in liver cancer
A randomized open-label phase II study on the effect of durvalumab and tremelimumab combined with personalized SIRT (p-SIRT), standard-dose SIRT (sd-SIRT) or immunotherapy followed by on-demand loco-regional SIRT (od-SIRT) in non-resectable hepatocellular carcinoma (HCC) patients
Source: EU CTIS (euclinicaltrials.eu) · Last updated 15 Jul 2026
Brief summary (registry, in English)
To assess the objective response rate in non-resectable HCC patients employing a treatment strategy with first-line systemic treatment in combination with personalized SIRT compared to standard SIRT (historical control)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 18 Jul 2024
- Start date
- 21 Dec 2023
- Lead sponsor
- Klinikum der Universitaet Muenchen AöR
- Diseases
- Liver and biliary tract cancer
- EU CT number
- 2024-515127-11-00
- EudraCT number
- 2020-003925-42
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 64
- 6 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with liver cancer (HCC) that cannot be removed by surgery but can be treated inside the liver area. They must not have had drug treatment for it before.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- HCC confirmed by tissue examination. Disease cannot be treated by surgery or ablation, but local liver treatment is possible. Portal vein invasion Vp1-3 is allowed. Liver function must be Child-Pugh A or B7. ECOG performance status 0 or 1.
- Earlier treatment
- No earlier drug treatment for HCC, including earlier checkpoint inhibitor or VEGF inhibitor treatment. No earlier TACE or SIRT in the same liver area if the tumour is active there, or if it came back within 6 months.
Main reasons for not taking part
- Diffuse HCC, spread outside the liver, Vp4 portal vein invasion, more than 7 lesions, or a lesion of 10 cm or more
- Poor liver function: troublesome ascites, hepatic encephalopathy, or Child-Pugh 8 points or more
- Major gut bleeding within 4 weeks before joining
- Infection with both HBV and HCV
- Fibrolamellar HCC, sarcomatoid HCC, or mixed bile duct cancer and HCC
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major gastrointestinal bleeding within 4 weeks prior to inclusion
- Decompensated liver function as defined by any of the following: Clinically meaningful ascites, hepatic encephalopathy or history of hepatic encephalopathy, Child Pugh ≥8 points. The presence of clinically meaningful ascites is defined as any ascites requiring non-pharmacologic intervention (eg, paracentesis) to maintain symptomatic control, within 6 months prior to the first scheduled dose. Subjects on stable doses of diuretics for ascites for ≥2 months are eligible.
- Prior systemic therapy for HCC (including previous CPI or VEGFi treatment)
- Prior treatment with TACE or SIRT if active tumor recurrence is located in previously treated hepatic segment or recurrence within ≤ 6 months after prior TACE or SIRT
Other illness
- Co-infection of HBV and HCV. Patients with a history of HCV infection but who are negative for HCV RNA by polymerase chain reaction (PCR) will be considered non-infected with HCV.
Other
- Diffuse HCC or presence of vascular invasion in the portal vein main stem (Vp4) or extrahepatic spread (including extrahepatic lymph node affection or metastasis) or more than 7 lesions or at least one lesion ≥ 10 cm
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Uncontrolled pleural effusion or pericardial effusion
- Ineligibility for locoregional treatment
Who the study is looking for
- Histological diagnosis of HCC
- Life expectancy of at least 12 weeks
- Disease which is not amenable to curative surgical or ablation treatment but eligible for locoregional treatment including portal vein invasion Vp1-3. Patients who are candidates for liver transplantation list are eligible at the discretion of the local investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Preserved liver function, as defined by a Child-Pugh score A and B7
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charite Universitaetsmedizin Berlin KöR | Berlin | Germany | Recruiting |
| Universitaetsklinikum Essen (AoR) | Essen | Germany | Recruiting |
| Universitaet Leipzig | Leipzig | Germany | Recruiting |
| Universitaetsklinikum Magdeburg AöR | Magdeburg | Germany | Recruiting |
| Klinikum der Universitaet Muenchen AöR | Munich | Germany | Recruiting |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.