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Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

NCT03298451

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Hepatocellular Carcinoma

Interventions: Durvalumab, Tremelimumab (Regimen 1), Tremelimumab (Regimen 2), Sorafenib, Durvalumab (Regimen 1)

Countries: United States, Brazil, Canada, China, France, Germany, Hong Kong, India

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

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

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
Locations (160)
  • Los Angeles, California, United States
  • Orange, California, United States
  • San Francisco, California, United States
  • Washington D.C., District of Columbia, United States
  • Fort Myers, Florida, United States
  • Jacksonville, Florida, United States
  • Westwood, Kansas, United States
  • Baltimore, Maryland, United States
  • Ann Arbor, Michigan, United States
  • Rochester, Minnesota, United States
  • New York, New York, United States
  • Charlotte, North Carolina, United States
  • Portland, Oregon, United States
  • Pittsburgh, Pennsylvania, United States
  • Dallas, Texas, United States
  • Dallas, Texas, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Houston, Texas, United States
  • Murray, Utah, United States
  • Barretos, Brazil
  • Curitiba, Brazil
  • Florianópolis, Brazil
  • Porto Alegre, Brazil
  • Rio de Janeiro, Brazil
  • São Paulo, Brazil
  • Calgary, Alberta, Canada
  • Edmonton, Alberta, Canada
  • Hamilton, Ontario, Canada
  • Kingston, Ontario, Canada
  • + 130 more on CT.gov