Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Loc… (NCT05301842) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC
United States760 participantsStarted 2022-03-28
Plain-language summary
A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma
Who can participate
Age range18 Years – 120 Years
SexALL
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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
What they're measuring
1
Progression Free Survival (PFS) for Arm A vs Arm C