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Clinical Trials List

Protocol NumberD910VC00001
NCT Number(ClinicalTrials.gov Identfier)NCT05301842
Active

2022-03-31 - 2027-12-31

Phase III

Recruiting6

ICD-10C22.0

Liver cell carcinoma

ICD-10C22.2

Hepatoblastoma

ICD-10C22.3

Angiosarcoma of liver

ICD-10C22.4

Other sarcomas of liver

ICD-10C22.7

Other specified carcinomas of liver

ICD-10C22.8

Malignant neoplasm of liver, primary, unspecified as to type

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9155.0

Malignant neoplasm of liver, primary

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

    2026/02/01

Investigators and Locations

Principal Investigator Yee Chao Division of Hematology & Oncology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TENG-YU LEE Digestive System Department

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Hung Hsu Division of Hematology & Oncology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chen-Chun Lin Digestive System Department

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chang-Fang Chiu Division of Hematology & Oncology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ting-Tsung Chang

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Hepatocellular Carcinoma

Objectives

This is a phase III, parallel, randomized, open-label, commissioner-blinded, 3-group, multicenter, global trial designed to evaluate the efficacy and safety of durvalumab + tremelimumab + TACE with or without lenvatinib compared with TACE alone in patients with localized regional HCC who are ineligible for curative treatments (e.g., surgical resection, transplantation, or cauterization).

Test Drug

靜脈點滴注射劑
靜脈點滴注射劑

Active Ingredient

Durvalumab
Tremelimumab

Dosage Form

242
242

Dosage

50mg
20mg

Endpoints

In patients with localized HCC, the efficacy of durvalumab + tremelimumab + lenvatinib + TACE was demonstrated to be superior to TACE alone by assessing progression-free survival (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