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Active Not Recruiting
NCT05301842
Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC
Conditions: Hepatocellular Carcinoma
Sex: All
Ages: 18 Years – 120 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 760
Sponsor: AstraZeneca
Location: Research Site Birmingham Alabama
Summary
A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma
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
Source: ClinicalTrials.gov (NCT05301842). StuddyBuddy aggregates publicly available trial information.