A Study Evaluating the Efficacy and Safety of Neoadjuvant ImmunotherapyCombinations in Patients with Surgically Resectable Hepatocellular Carcinoma (Morpheus-Neo HCC)
- Conditions
- Hepatocellular Carcinoma (Morpheus-Neo HCC)MedDRA version: 20.0Level: PTClassification code: 10073071Term: Hepatocellular carcinoma Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2022-502840-11-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 143
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
Presence of extrahepatic disease or macrovascular invasion, Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinoma and HCC, or other rare variants of HCC, History of hepatic encephalopathy, Moderate or severe ascites, Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method