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Evaluating the efficacy and safety of transarterial chemoembolization (TACE) in combination with immunotherapy and targeted therapy versus TACE alone in patients with regionally localized hepatocellular carcinoma

Study Status

Completed

Phase

Phase 3

Therapeutic Area

Liver Cancer

Overview

Hepatocellular carcinoma (HCC) is the fourth leading cause of cancer-related death worldwide. Most patients are diagnosed at an intermediate stage, when curative treatment options are no longer appropriate. TACE is a commonly used locoregional therapy, but its benefits are often not durable and the risk of recurrence is high. This study evaluates combination therapy with immune checkpoint inhibitors (durvalumab + tremelimumab) ± the targeted agent lenvatinib plus TACE, compared with TACE alone, with the expectation of improving tumor control, preventing recurrence, and prolonging survival in patients with regionally localized HCC.

Inclusion Criteria

Men and women aged ≥18 years, body weight >30 kg
HCC confirmed by histology or characteristic imaging
Disease confined to the liver, without extrahepatic metastasis, and eligible for TACE
Preserved liver function (Child-Pugh class A, 5–6 points) and good performance status (ECOG 0–1)

Exclusion Criteria

Prior systemic therapy or prior TACE with palliative intent.
Significant cardiovascular or systemic disease, as well as uncontrolled active infections such as hepatitis B/C, HIV, or tuberculosis

PI

MSc, MD Quách Thanh Dung – Oncology Center, Vinmec Times City Internation Hospital

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