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

• Status: Not yet recruiting
• Trial end date: 2027-01-29
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Durvalumab; Lenvatinib; Tremelimumab

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