advanced hepatocellular carcinoma (HCC) MedDRA version: 21.0 Level: LLT Classification code 10019828 Term: Hepatocellular carcinoma non-resectable System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: durvalumab
Product Code: MEDI4736
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: durvalumab
CAS Number: 1428935-60-7
Current Sponsor code: MEDI4736
Conce
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - HCC based on histopathological confirmation - No prior systemic therapy for HCC - Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C - Child-Pugh Score class A - ECOG performance status of 0 or 1 at enrollment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 990 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 660
Exclusion criteria
Exclusion criteria: - Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy - Clinical meaningful ascites - Main portal vein thrombosis - Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 12 months - HBV and HVC coinfection, or HBV and Hep D coinfection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of durvalumab plus tremelimumab combination therapy compared with sorafenib.;Secondary Objective: - To assess the efficacy of durvalumab monotherapy compared with sorafenib - To assess the safety and tolerability profile across all treatment arms - To assess the efficacy of Durvalumab monotheraphy and Durvalumab plus tremelimumab combination theraphy compared with sorafenib by PD-L1 expression - To assess disease-related symptoms, impacts, and health-related quality of life (HRQoL) in Durvalumab monotheraphy and Durvalumab plus tremelimimab combination therapy compared with sorafenib - To evaluate the population PK and pharmacodynamics of Durvalumab monotheraphy and Durvalumab plus tremelimumab combination therapy - To investigate the immunogenicity of Durvalumab monotheraphy and Durvalumab plus tremelimumab combination therapy;Primary end point(s): Overall survival (OS) is defined as the time from the date of randomization until death due to any cause.;Timepoint(s) of evaluation of this end point: Patient level: Assessments for survival will be made every 4 weeks during treatment period and every 2 months following treatment discontinuation which will continue until the end of the study unless the patient has expressly withdrawn their consent to survival follow-up. In addition, all patients will be contacted in the week following data cutoff to confirm survival status. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Other secondary efficacy endpoints include: Progression-free survival (PFS), Time to progression (TTP), Objective response rate (ORR), Disease control rate (DCR), and Duration of response (DoR);Timepoint(s) of evaluation of this end point: PFS, TTP, ORR, DCR, DoR - Patient level: Efficacy for all patients will be assessed by objective tumor assessments every 8 weeks (±1 week) for the first 48 weeks (relative to the date of randomization; then every 12 weeks (±1 week) thereafter until confirmed PD as defined by RECIST 1.1 or discontinuation from study participation. | — |
Countries
Brazil, Canada, China, France, Germany, Hong Kong, India, Italy, Japan, Korea, Republic of, Russian Federation, Spain, Taiwan, Thailand, Ukraine, United States, Viet Nam
Contacts
Public ContactStudy Information Center
AstraZeneca Clinical
Outcome results
None listed