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Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC
Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC

NCT05301842

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Hepatocellular Carcinoma

Interventions: Tremelimumab, Durvalumab, Transarterial Chemoembolization (TACE), Lenvatinib

Countries: United States, Belgium, Brazil, Canada, China, Egypt, France, Germany

A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma

Eligibility overview

Sex: ALL

Age: 18 Years to 120 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* No evidence of extrahepatic disease
* Disease not amenable to curative surgery or transplantation or curative ablation but disease amenable to TACE
* Child Pugh score class A
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
* Measurable disease by Modified Response Criteria in Solid Tumors (mRECIST) criteria
* Adequate organ and marrow function

Exclusion Criteria:

* History of symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardia arrhythmia
* History of hepatic encephalopathy
* Major portal vein thrombosis visible on baseline imaging
* Uncontrolled arterial hypertension
* Co-infection with HBV and HDV
Locations (171)
  • Birmingham, Alabama, United States
  • Mobile, Alabama, United States
  • Yuma, Arizona, United States
  • Glendale, California, United States
  • Atlanta, Georgia, United States
  • Baltimore, Maryland, United States
  • Santa Fe, New Mexico, United States
  • Commack, New York, United States
  • New York, New York, United States
  • Memphis, Tennessee, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Brussels, Belgium
  • Ghent, Belgium
  • Barretos, Brazil
  • Brasília, Brazil
  • Niterói, Brazil
  • Porto Alegre, Brazil
  • Rio de Janeiro, Brazil
  • Santa Maria, Brazil
  • Santo André, Brazil
  • São Paulo, Brazil
  • Vitória, Brazil
  • Calgary, Alberta, Canada
  • Halifax, Nova Scotia, Canada
  • Kingston, Ontario, Canada
  • Ottawa, Ontario, Canada
  • Toronto, Ontario, Canada
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • + 141 more on CT.gov