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Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Trial Status: closed to accrual
This is a randomized, open-label, multi-center, global, Phase III study to assess the
efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab
monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy
for unresectable HCC. The patients cannot be eligible for locoregional therapy
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
Exclusion Criteria
Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy
Clinically meaningful ascites
Main portal vein tumor thrombosis
Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 12 months
HBV and HVC co-infection, or HBV and Hep D co-infection
Additional locations may be listed on ClinicalTrials.gov for NCT03298451.
Locations matching your search criteria
United States
Kansas
Fairway
University of Kansas Clinical Research Center
Status: Active
Name Not Available
Kansas City
University of Kansas Cancer Center
Status: Active
Name Not Available
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: Active
Name Not Available
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Name Not Available
North Carolina
Durham
Duke University Medical Center
Status: Active
Name Not Available
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available
The study population includes patients 18 years of age or older with advanced HCC,
Barcelona Clinic Liver Cancer stage B not eligible for locoregional therapy or stage C,
and Child-Pugh A classification liver disease. Patients must not have received any prior
systemic therapy for unresectable HCC.
Patients in all treatment arms may continue receiving their originally assigned
treatment, at the Investigator's discretion, until progression
Patients in all arms with confirmed PD who, in the Investigator's opinion, continue to
receive benefit from their assigned treatment and meet the criteria for treatment in the
setting of PD may continue to receive their assigned treatment.
If a patient discontinues study drug(s) due to disease progression, the patient will
enter survival follow-up. Patients who have discontinued treatment due to toxicity or
symptomatic deterioration or who have commenced subsequent anticancer therapy, will have
tumor assessments until confirmed PD and will be followed for survival
