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

Phase 3

Active, not recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Tremelimumab; Drug: Durvalumab; Procedure: Transarterial Chemoembolization (TACE); Drug: Lenvatinib

• Registration Number: NCT05301842
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

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).

Study Timeline

• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-03-21
• Study Start: 2022-03-28
• Study First Posted: 2022-03-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-15
• Primary Completion: 2025-12-31
• Study Completion: 2027-02-26

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 760

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Tremelimumab	Tremelimumab, Durvalumab and Lenvatinib in combination with Transarterial Chemoembolization (TACE)
Arm A	Durvalumab	Tremelimumab, Durvalumab and Lenvatinib in combination with Transarterial Chemoembolization (TACE)
Arm A	Transarterial Chemoembolization (TACE)	Tremelimumab, Durvalumab and Lenvatinib in combination with Transarterial Chemoembolization (TACE)
Arm A	Lenvatinib	Tremelimumab, Durvalumab and Lenvatinib in combination with Transarterial Chemoembolization (TACE)
Arm B	Tremelimumab	Tremelimumab and Durvalumab in combination with Transarterial Chemoemobolization (TACE)
Arm B	Transarterial Chemoembolization (TACE)	Tremelimumab and Durvalumab in combination with Transarterial Chemoemobolization (TACE)
Arm C	Transarterial Chemoembolization (TACE)	Transarterial Chemoembolization (TACE)
Arm B	Durvalumab	Tremelimumab and Durvalumab in combination with Transarterial Chemoemobolization (TACE)

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) for Arm A vs Arm C	Approximately 5 years	PFS is defined as time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS) for Arm B vs Arm C	Approximately 5 years	OS is defined as the time from the date of randomization until death due to any cause
Overall Survival (OS) for Arm A vs Arm C	Approximately 5 years	OS is defined as the time from the date of randomization until death due to any cause
Progression Free Survival (PFS) for Arm B vs Arm C	Approximately 5 years	PFS is defined as time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause

Trial Locations

Locations (1)

Research Site; 🇻🇳 Ho Chi Minh, Vietnam