Loading clinical trials...

A Study Evaluating The Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients With Surgically Resectable Hepatocellular Carcinoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

A Phase Ib/II, Open-Label, Multicenter, Randomized Platform Study Evaluating The Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients With Surgically Resectable Hepatocellular Carcinoma (MORPHEUS-NEO HCC)

NCT05908786•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+1 more criteria

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
+14 more criteria

Locations (30)

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

Key Dates

Start Date

December 5, 2023

Primary Completion Date

August 27, 2025

Completion Date

November 13, 2025

Last Updated

December 11, 2025

Enrollment

ACTUAL participants

Conditions

Carcinoma, Hepatocellular

Interventions

Atezolizumab

DRUG

Bevacizumab

DRUG

Tiragolumab

DRUG

Tobemstomig

DRUG

Adjuvant Adebrelimab Plus Apatinib for Participants With HCC at High-risk of Recurrence After Curative Resection

NCT06454578

Carcinoma, Hepatocellular

View study

RECRUITING

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

NCT05870969

Carcinoma, HepatocellularHepatitis C, Chronic+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Adjuvant Adebrelimab Plus Apatinib for Participants With HCC at High-risk of Recurrence After Curative Resection

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

SBRT for Hepatocellular Carcinoma Patients With Partial Response to TACE

Pembrolizumab and Lenvatinib for Resectable Hepatocellular Carcinoma

A Study of Atezolizumab in Combination With Bevacizumab in Spanish Patients With Unresectable or Unsuitable for Locoregional Treatments Hepatocellular Carcinoma Not Previously Treated With Systemic Therapy

Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-42756493 (Erdafitinib) in Participants With Advanced Hepatocellular Carcinoma