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

NCT05301842 · tracked via the Priya Life Science India tracker

Sponsor

AstraZeneca

Phase

Phase 3

Started

2022-03-28

Last updated

2026-07-13

Condition(s) studied

Hepatocellular Carcinoma

Investigational drug(s) / intervention(s)

TremelimumabDurvalumabTransarterial Chemoembolization (TACE)Lenvatinib

Tremelimumab: Tremelimumab IV (intravenous)

Durvalumab: Durvalumab IV (intravenous)

Transarterial Chemoembolization (TACE): TACE (chemo and embolic agent injection into the hepatic artery)

Lenvatinib: Lenvatinib (oral)

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

120 Years

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (171)

Facility	City	Region
Research Site	Birmingham	Alabama
Research Site	Mobile	Alabama
Research Site	Yuma	Arizona
Research Site	Glendale	California
Research Site	Atlanta	Georgia
Research Site	Baltimore	Maryland
Research Site	Santa Fe	New Mexico
Research Site	Commack	New York
Research Site	New York	New York
Research Site	Memphis	Tennessee
Research Site	Dallas	Texas
Research Site	Houston	Texas
Research Site	Brussels	Belgium
Research Site	Ghent	Belgium
Research Site	Barretos	Brazil
Research Site	Brasília	Brazil
Research Site	Niterói	Brazil
Research Site	Porto Alegre	Brazil
Research Site	Rio de Janeiro	Brazil
Research Site	Santa Maria	Brazil
Research Site	Santo André	Brazil
Research Site	São Paulo	Brazil
Research Site	Vitória	Brazil
Research Site	Calgary	Alberta
Research Site	Halifax	Nova Scotia
Research Site	Kingston	Ontario
Research Site	Ottawa	Ontario
Research Site	Toronto	Ontario
Research Site	Toronto	Ontario
Research Site	Montreal	Quebec
Research Site	Montreal	Quebec
Research Site	Beijing	China
Research Site	Beijing	China
Research Site	Beijing	China
Research Site	Changchun	China
Research Site	Changsha	China
Research Site	Chengdu	China
Research Site	Fuzhou	China
Research Site	Fuzhou	China
Research Site	Guangzhou	China

+ 131 more sites — see the full list on the official registry below.

On this site

📄 Imfinzi (durvalumab) drug profile → 📄 Lenvima (lenvatinib) drug profile →

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Other trials for the same condition

Phase II Trial of Immunonutrition in Hepatectomy Recruiting

A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma Active, not recruiting

Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment Active, not recruiting

Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma Active, not recruiting

Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05301842 on ClinicalTrials.gov ↗ ← All trials in India