Patients with hepatocellular cancer, not amenable to curative surgical or ablation treatment. MedDRA version: 21.0 Level: LLT Classification code 10036706 Term: Primary liver cancer non-resectable System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Clinics of Munich University LMU
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Histological diagnosis of HCC * Life expectancy of at least 12 weeks * Disease which is not amenable to curative surgical or ablation treatment but eligible for TACE with tumor burden =65 years) yes F.1.3.1 Number of subjects for this age range 28
Exclusion criteria
Exclusion criteria: * Diffuse HCC or presence of vascular invasion or extrahepatic spread (including extrahepatic lymph node affection or metastasis) or more than 7 lesions or at least one lesion = 7 cm * Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC * Decompensated liver function as defined by any of the following: Clinically meaningful ascites, hepatic encephalopathy or history of hepatic encephalopathy, Child Pugh =7 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 * Uncontrolled pleural effusion or pericardial effusion * 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. * Patients on a liver transplantation list * Prior systemic therapy for HCC (including previous CPI or VEGFi treatment) * Prior treatment with TACE or SIRT * Ineligibility for locoregional treatment * Major gastrointestinal bleeding within 4 weeks prior to inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: *To assess Objective Response Rate in non-resectable HCC patients treated with first-line systemic treatment in association with SIRT;Secondary Objective: * To evaluate the safety and quality of life of treatment with durvalumab/tremelimumab in combination with SIRT * To evaluate overall survival, progression-free survival, time to progression, and disease control rate of patients treated with durvalumab/tremelimumab in combination with SIRT ;Primary end point(s): Objective Response Rate ;Timepoint(s) of evaluation of this end point: every 2/3 months during 12 months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): * Overall survival (calculated form the day of randomization) * Progression-free survival (calculated from the day of randomization); to be evaluated both according to RECIST 1.1 as well as mRECIST * Time to progression (calculated from the day of randomization); to be evaluated both according to RECIST 1.1 as well as mRECIST * Disease control rate at the end of study (12 months FU); to be evaluated both according to RECIST 1.1 as well as mRECIST * Quality of Life: QoL scores from EORTC QLQ-C30 and EORTC QLQ-HCC18 questionnaires * Safety: adverse events * Safety: changes in vital signs (heart rate, blood pressure) * Safety: changes in weight * Safety: shift of laboratory parameters (e.g., from normal to abnormal) ;Timepoint(s) of evaluation of this end point: every 2/3 months during 12 months follow-up | — |
Countries
Germany
Contacts
Public ContactClinical Trials Office
Clinics of Munich University LMU
Outcome results
None listed