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

What this trial studies

This is a Phase III, parallel, randomized, open-label, sponsor-blinded, 3-arm, multicenter, international study assessing the efficacy and safety of durvalumab + tremelimumab + TACE with or without lenvatinib compared with TACE alone in participants with locoregional HCC not amenable to curative therapy (eg, surgical resection, transplantation, or ablation).

Who can join: the full rules

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

Where it's running

• Research Site
  Birmingham, Alabama, United States
• Research Site
  Mobile, Alabama, United States
• Research Site
  Yuma, Arizona, United States
• Research Site
  Glendale, California, United States
• Research Site
  Atlanta, Georgia, United States
• Research Site
  Baltimore, Maryland, United States

+121 more sites. See ClinicalTrials.gov for the full list.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.