A Study Evaluating The Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients With Surgically Resectable Hepatocellular Carcinoma

Completed · Phase 1/Phase 2

Conditions studied: Carcinoma, Hepatocellular

In brief

This is a Phase Ib/II, open-label, multicenter, randomized platform study to evaluate neoadjuvant immunotherapy combinations in participants with resectable HCC. The study is designed with the flexibility to open new treatment arms as new agents become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population.

Key facts

Study ID

NCT05908786

Run by

Hoffmann-La Roche

People needed

62

Starts

2023-12-05

Expected to finish

2025-11-13

Last updated by the study team

2025-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of HCC confirmed either histologically or clinically according to AASLD criteria for patients with cirrhosis. For participants without cirrhosis, histological confirmation is mandatory.
• 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. Patients presenting with resectable HCC within or beyond Milan criteria (without extrahepatic spread or macrovascular invasion) are eligible.
• Measurable disease (at least one target lesion) according to 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
• Negative HIV test at screening
• No prior locoregional or systemic treatment for HCC
• Adequate hematologic and end-organ function
• Documented virology status of hepatitis
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating sperm
• General Exclusion Criteria:
• 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 if clinically significant within one year prior to initiation of study treatment
• Moderate or severe ascites
• Active co-infection with HBV and HCV
• Known active co-infection with HBV and hepatitis D viral infection
• Prior treatment with CD137 agonists or immune checkpoint inhibitors, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
• Treatment with investigational therapy within 28 days prior to initiation of study treatment
• Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
• A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
• Inadequately controlled hypertension
• History of hypertensive crisis or hypertensive encephalopathy
• Significant vascular disease within 6 months prior to initiation of study treatment

Where it is running

• University of Southern California (USC) — Los Angeles, California, United States
• University of California Los Angeles (UCLA) - Cancer Care - Santa Monica — Santa Monica, California, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Barbara Ann Karmanos Cancer Institute - Karmanos Cancer Center - Main Campus — Detroit, Michigan, United States
• Columbia University Medical Center — New York, New York, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• Klinikum Klagenfurt am Wörthersee — Klagenfurt, Austria
• Wiener Gesundheitsverbund, Klinik Favoriten — Vienna, Austria
• Department of Internal Medicine III AKH and Medical University of Vienna — Vienna, Austria
• Centre Georges Francois Leclerc (CGFL) — Dijon, France
• Centre Eugene Marquis (CEM) — Rennes, France
• Assistance Publique-Hopitaux de Paris — Villejuif, France
• Gustave Roussy — Villejuif, France
• University Essen — Essen, Germany
• Universitaets Klinikum Frankfurt - Zentrum der Inneren Medizin — Frankfurt, Germany
• Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz — Mainz, Germany
• Auckland District Health Board (ADHB) — Auckland, New Zealand
• CHA Bundang Medical Center — Seongnam-si, Gyeonggi-do, South Korea
• Severance Hospital, Yonsei University Health System — Seoul, South Korea
• Asan Medical Center — Seoul, South Korea
• Hospital Universitario Marques de Valdecilla — Santander, Cantabria, Spain
• Clínica Universidad de Navarra — Pamplona, Navarre, Spain
• Hospital Clinic de Barcelona (Hospital Clinic i Provincial) — Barcelona, Spain
• Hospital Universitario Fundacion Jimenez Diaz. — Madrid, Spain
• Taichung Veterans General Hospital — Taichung, Taiwan

Full record on ClinicalTrials.gov

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