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Clinical Trials in Italy / NCT05301842
Active, not recruiting Phase 3

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

NCT05301842 · tracked via the Priya Life Science Italy 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)

Tremelimumab →Durvalumab →Transarterial 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
No
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)

FacilityCityRegionStatus
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 →

More AstraZeneca trials in Italy

PASS of Paediatric Patients Initiating Selumetinib Active, not recruiting
A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer Recruiting
AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer Recruiting
Acalabrutinib Real World Italian obSErvational Study -ARISE Active, not recruiting
Observational Study on the Clinical Profile of Patients With Uncontrolled Severe Asthma Treated With Tezepelumab in Italy Active, not recruiting

Other trials for the same condition

Prognostic Factors for HCC and Liver Transplantation in Patients With MASLD/MASH Recruiting
The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (#HOPE4LIVER EU/UK) Active, not recruiting
Liver Embolization Approaches for Tumor Management Recruiting
A Phase I Trial of IMA970A Plus Montanide in Combination With Durvalumab (Anti-PD-L1) Active, not recruiting
Tumor Antigen Discovery for Innovative Cancer Immunotherapies in HCC: from Benchside to Bedside (HepAnt) 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 Italy