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Prospective, multicenter registry trial to evaluate the efficacy of immunotherapy in patients with advanced hepatocellular carcinoma (HCC)

Prospective, multicenter registry trial to evaluate the efficacy of immunotherapy in patients with advanced hepatocellular carcinoma (HCC)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00034838
Enrollment
400
Registered
2024-08-29
Start date
2024-01-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C22.0

Interventions

Group 1: Patients with advanced HCC and immunotherapy-based first-line therapy Patients are included at the timepoint of therapy initiation. Epidemilogical-, clinical- as well as laboratory parameter

Sponsors

Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with advanced HCC (Barcelona Clinic Liver Cancer (BCLC) classification B/C) and planned first-line systemic treatment using immunotherapy (combination therapy) in accordance with the decision of the local tumor conference The HCC must have arisen from the following etiologies: MASLD, alcohol-induced liver cirrhosis, viral-induced liver cirrhosis

Exclusion criteria

Exclusion criteria: Previous systemic therapy or treatment with immune checkpoint inhibitors (only for HCC) HCC due to the following liver diseases: cryptogenic liver cirrhosis, autoimmune hepatitis (AIH), primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), haemochromatosis, Wilson's disease, alpha-1-antitrypsin deficiency Combined hepatocellular-cholangiocellular carcinoma, fibrolamellar HCC No written consent possible

Design outcomes

Primary

MeasureTime frame
Overall survival (defined as the time-interval between study inclusion at the start of treatment and the patient's death) Survival data is collected either by notification of the relatives or by telephone contact

Secondary

MeasureTime frame
objective response rate (defined as best tumor response under therapy) The data is recorded on the basis of the quarterly imaging diagnostics performed as part of the clinical routine

Countries

Germany

Contacts

Public ContactCatherine Leyh

Universitätsklinikum Düsseldorf, Klinik für Gastroenterologie, Hepatologie und Infektiologie

catherine.leyh@med.uni-duesseldorf.de0049 211 81 08030

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026