Clinical trial · Interventional
Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC
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)
NCT05301842CI-TRIAL-00117740EMERALD-3active not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Drug | Durvalumab | ALIAS |
| Lenvatinib | Drug | Lenvatinib | ALIAS |
| Transarterial Chemoembolization (TACE) | Procedure | — | UNRESOLVED |
| Tremelimumab | Drug | Tremelimumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Tremelimumab, Durvalumab and Lenvatinib in combination with Transarterial Chemoembolization (TACE)
- interventionNames
- Drug: Tremelimumab
- Drug: Durvalumab
- Procedure: Transarterial Chemoembolization (TACE)
- Drug: Lenvatinib
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Tremelimumab and Durvalumab in combination with Transarterial Chemoemobolization (TACE)
- interventionNames
- Drug: Tremelimumab
- Drug: Durvalumab
- Procedure: Transarterial Chemoembolization (TACE)
- type
- ACTIVE_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKudo M, Abou-Alfa GK, Ren Z, Heo J, Lencioni R, Arai Y, Bouattour M, Gonzalez-Carmona MA, Guo Y, Xu AB, Alves GV, Dechaphunkul A, Ho GF, Lim YN, Hu H, Liu R, Gu S, Ostwal V, Manasirisuk W, Chiu CF, Tekumalla SH, Shroff M, Dave V, Rahma O, Erinjeri JP, Fan J; EMERALD-3 Investigators. Durvalumab and tremelimumab, with or without lenvatinib, combined with transarterial chemoembolisation in participants with embolisation-eligible hepatocellular carcinoma (EMERALD-3): a global, randomised, open-label, sponsor-blinded, phase 3 study. Lancet Oncol. 2026 Sep;27(9):1077-1093. doi: 10.1016/S1470-2045(26)00278-0. PMID 42636832