Study on the effect of 2 immunotherapy drugs in combination with radioactive glass spheres on the survival in liver cancer
Key facts
- Where
- Berlin, Essen, Leipzig, Magdeburg és Munich, NémetországSee the 5 sites
- Phase
- 2. fázis
Where in Németország
- Charite Universitaetsmedizin Berlin KöRBerlin, NémetországTaking people
- Universitaetsklinikum Essen (AoR)Essen, NémetországTaking people
- Universitaet LeipzigLeipzig, NémetországTaking people
- Universitaetsklinikum Magdeburg AöRMagdeburg, NémetországTaking people
- Klinikum der Universitaet Muenchen AöRMunich, NémetországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Klinikum der Universitaet Muenchen AöR
- Trial code
- EU 2024-515127-11-00
- Record updated
- 2026. július 15.
- Original description
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)Read full original descriptionShow less
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
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)
Inclusion: 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.
Exclusion: 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; 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; 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.