Durvalumab for Hepatocellular carcinoma

Inclusion criteria

• {"criterion_text":"- Histological diagnosis of HCC\n- Life expectancy of at least 12 weeks\n- Disease which is not amenable to curative surgical or ablation treatment but eligible for locoregional treatment including portal vein invasion Vp1-3. Patients who are candidates for liver transplantation list are eligible at the discretion of the local investigator.\n- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n- Preserved liver function, as defined by a Child-Pugh score A and B7"}

Exclusion criteria

• {"criterion_text":"- Diffuse HCC or presence of vascular invasion in the portal vein main stem (Vp4) or extrahepatic spread (including extrahepatic lymph node affection or metastasis) or more than 7 lesions or at least one lesion ≥ 10 cm\n- Major gastrointestinal bleeding within 4 weeks prior to inclusion\n- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC\n- Decompensated liver function as defined by any of the following: Clinically meaningful ascites, hepatic encephalopathy or history of hepatic encephalopathy, Child Pugh ≥8 points. The presence of clinically meaningful ascites is defined as any ascites requiring non-pharmacologic intervention (eg, paracentesis) to maintain symptomatic control, within 6 months prior to the first scheduled dose. Subjects on stable doses of diuretics for ascites for ≥2 months are eligible.\n- Uncontrolled pleural effusion or pericardial effusion\n- Co-infection of HBV and HCV. Patients with a history of HCV infection but who are negative for HCV RNA by polymerase chain reaction (PCR) will be considered non-infected with HCV.\n- Prior systemic therapy for HCC (including previous CPI or VEGFi treatment)\n- Prior treatment with TACE or SIRT if active tumor recurrence is located in previously treated hepatic segment or recurrence within ≤ 6 months after prior TACE or SIRT\n- Ineligibility for locoregional treatment"}

Primary endpoints

• {"endpoint_text":"- Objective Response Rate (ORR compared to SIRT historical control)","definition_or_measurement_approach":"Objective Response Rate (ORR) compared to SIRT historical control (as stated: ORR compared to SIRT historical control)."}

Secondary endpoints

• {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Progression-free survival (PFS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Complete response rate (CRR)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Disease control rate (DCR)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Duration of response (DoR)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time to deterioration of liver function, defined as time from randomization to worsening of CTCAE grade compared with baseline and persisting for ≥30 days for any of these parameters: aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, albumin, and international normalized ratio (INR); separately for patients in Arm A and Arm B","definition_or_measurement_approach":"Defined as time from randomization to worsening of CTCAE grade compared with baseline and persisting for ≥30 days for any of AST, ALT, total bilirubin, albumin, and INR; evaluated separately by treatment arm."}
• {"endpoint_text":"- Time to locally/locoregional untreatable progression (TTuP), defined as time from randomization to occurrence of any of the following conditions: progression which would require targeting of more than 3 pretreated lesions as determined by the latest staging investigation, progression occurring due to diffuse tumor growth, occurrence of vascular invasion, occurrence of extrahepatic spread, worsening of liver function to Child-Pugh score 8 or higher","definition_or_measurement_approach":"Defined as time from randomization to progression meeting any listed conditions (need for targeting >3 pretreated lesions, diffuse tumor growth, vascular invasion, extrahepatic spread, or worsening liver function to Child‑Pugh ≥8)."}
• {"endpoint_text":"- Time to stage progression (defined as time from randomization to disease progression to BCLC C)","definition_or_measurement_approach":"Defined as time from randomization to progression of disease stage to BCLC C."}
• {"endpoint_text":"- To assess the quality of life (QoL), as determined by the EORTC QLQ-C30 and EORTC QLQ-HCC18 questionnaires.","definition_or_measurement_approach":"Quality of life assessed using EORTC QLQ-C30 and EORTC QLQ-HCC18 questionnaires."}

Germany

Latest Decision Or Authorization Date

06-09-2024

Number Of Sites

4

Number Of Participants

60

Italy

Latest Decision Or Authorization Date

28-03-2025

Number Of Sites

1

Number Of Participants

4

Primary sponsor

Full Name

Klinikum der Universitaet Muenchen AöR

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany

Contract research organisations

Name

Pharmtrace klinische Entwicklung GmbH

Responsibilities

codes: [1,12,5,6,7,8]

Third parties

• {"country":"Germany","full_name":"Pharmtrace klinische Entwicklung GmbH","duties_or_roles":"codes: [1,12,5,6,7,8]","organisation_type":"Pharmaceutical company"}