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Clinical Trials List

Protocol NumberD910VC00001

NCT Number(ClinicalTrials.gov Identfier)NCT05301842

2022-03-31 - 2027-12-31

Phase III

Not yet recruiting4

Recruiting2

A Phase III, Randomized, Open-Label, Sponsor-Blinded, Multicenter Study of Durvalumab in Combination With Tremelimumab ± Lenvatinib Given Concurrently With TACE Compared to TACE Alone in Patients With Locoregional Hepatocellular Carcinoma (EMERALD-3)

Trial Applicant
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2025/08/20

Investigators and Locations

Principal Investigator I-Cheng Lee 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator TENG-YU LEE 無

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chih-Hung Hsu 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chen-Chun Lin 無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chang-Fang Chiu 無

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ting-Tsung Chang Digestive System Department

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Hepatocellular Carcinoma

Objectives

This is a Phase 3, parallel, randomized, open-label, sponsor-blinded, 3-arm, multicenter, global trial designed to evaluate the efficacy and safety of durvalumab + tremelimumab + TACE with or without lenvatinib compared with TACE alone in subjects with locoregional HCC who are not candidates for curative therapy (e.g., surgical resection, transplantation, or ablation).

Test Drug

DurvalumabTremelimumab

Active Ingredient

Durvalumab
Tremelimumab

Dosage Form

Injection
Injection

Dosage

50 mg/mL
20 mg/mL

Endpoints

To demonstrate the superiority of durvalumab + tremelimumab + lenvatinib + TACE over TACE alone in subjects with locoregional HCC by evaluating PFS

Inclution 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

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

The Estimated Number of Participants

Taiwan

60 participants
Global

725 participants