2022-502840-11-00CompletedPhase 1/2
A Study Evaluating the Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients with Surgically Resectable Hepatocellular Carcinoma (Morpheus-Neo HCC)
A PHASE IB/II, OPEN-LABEL, MULTICENTER, RANDOMIZED PLATFORM STUDY EVALUATING THE EFFICACY AND SAFETY OF NEOADJUVANT IMMUNOTHERAPY COMBINATIONS IN PATIENTS WITH SURGICALLY RESECTABLE HEPATOCEULLULAR CARCINOMA (MORPHEUS-NEO HCC)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 8 Dec 2025
Brief summary (registry, in English)
To evaluate the efficacy of neoadjuvant immunotherapy-based treatment combinations based on the major pathologic response (MPR) rate
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 55 (actual)
- First submitted
- 3 Jul 2023
- Start date
- 28 Nov 2023
- Lead sponsor
- F. Hoffmann-La Roche AG
- Diseases
- Liver and biliary tract cancer
- EU CT number
- 2022-502840-11-00
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 55
- 15 sites in 4 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.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence of extrahepatic disease or macrovascular invasion
- History of hepatic encephalopathy
- Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
Other
- Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinoma and HCC, or other rare variants of HCC
- Moderate or severe ascites
Who the study is looking for
- Diagnosis of HCC confirmed either histologically or clinically according to American Association for the Study of Liver Diseases (AASLD) criteria for patients with cirrhosis
- HCC that is amenable to R0 surgical resection with curative intent in the opinion of the surgeons and oncologists or hepatologists involved in the care of the participant
- Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as determined by the investigator
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days prior to randomization
- Child-Pugh Class A within 7 days prior to randomization
- No prior locoregional or systemic treatment for HCC
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Landeskrankenanstalten-Betriebsgesellschaft Kabeg | Klagenfurt Am Woerthersee | Austria | Completed |
| Medical University of Vienna | Vienna | Austria | Completed |
| Klinik Favoriten | Vienna | Austria | Completed |
| Universitaetsklinikum Essen (AoR) | Essen | Germany | Completed |
| Goethe University Frankfurt | Frankfurt Am Main | Germany | Completed |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR | Mainz | Germany | Completed |
| Hospital Clinic de Barcelona | Barcelona | Spain | Completed |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | Spain | Completed |
| Clínica Universidad de navarra | Pamplona | Spain | Completed |
| Hospital Universitario Marqués de Valdecilla | Santander | Spain | Completed |
| Centr Georges Francois Leclerc | Dijon | France | Completed |
| Centre Hospitalier Universitaire De Lille | Lille Cedex | France | Completed |
| Centre De Lutte Contre Le Cancer Eugene Marquis | Rennes Cedex | France | Completed |
| Institut Gustave Roussy | Villejuif | France | Completed |
| Hopital Paul Brousse | Villejuif Cedex | France | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.