A Study Evaluating the Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients with Surgically Resectable Hepatocellular Carcinoma (Morpheus-Neo HCC)
Key facts
- Where
- Dijon, Lille Cedex, Rennes Cedex, Villejuif és Villejuif Cedex, FranciaországSee the 5 sites
- Phase
- 1/2. fázis
Where in Franciaország
- Centr Georges Francois LeclercDijon, FranciaországNo longer taking part
- Centre Hospitalier Universitaire De LilleLille Cedex, FranciaországNo longer taking part
- Centre De Lutte Contre Le Cancer Eugene MarquisRennes Cedex, FranciaországNo longer taking part
- Institut Gustave RoussyVillejuif, FranciaországNo longer taking part
- Hopital Paul BrousseVillejuif Cedex, FranciaországNo longer taking part
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
- F. Hoffmann-La Roche AG
- Trial code
- EU 2022-502840-11-00
- Record updated
- 2025. december 8.
- Original description
To evaluate the efficacy of neoadjuvant immunotherapy-based treatment combinations based on the major pathologic response (MPR) rateRead full original descriptionShow less
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)
To evaluate the efficacy of neoadjuvant immunotherapy-based treatment combinations based on the major pathologic response (MPR) rate
Inclusion: 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.
Exclusion: 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; Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinoma and HCC, or other rare variants of HCC; Moderate or severe ascites.