Clinical trial · Interventional
A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma
A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Transarterial Chemoembolization (TACE) in Combination With Either Durvalumab Monotherapy or Durvalumab Plus Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma (EMERALD-1)
- 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 and bevacizumab 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 |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Durvalumab | Drug | Durvalumab | ALIAS |
| Placebo | Other | — | UNRESOLVED |
| Transarterial Chemoembolization (TACE) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Transarterial Chemoembolization (TACE) in combination with Durvalumab
- interventionNames
- Drug: Durvalumab
- Other: Placebo
- Procedure: Transarterial Chemoembolization (TACE)
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Transarterial Chemoembolization (TACE) in combination with Durvalumab and Bevacizumab
- interventionNames
- Drug: Durvalumab
- Drug: Bevacizumab
- Procedure: Transarterial Chemoembolization (TACE)
- type
- PLACEBO_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 110 Years
Show eligibility criteria text
Key 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 to B7 and 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 Key Exclusion Criteria * Any history of nephrotic or nephritic syndrome * Clinically significant cardiovascular disease or history of arterioembolic event including a stroke or myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within 6 months prior to randomization * Any prior or current evidence of coagulopathy or bleeding diathesis or patients who had any kind of surgery in the past 28 days (biopsies are exempt from this exclusion) * History of abdominal fistula or GI perforation, non healed gastric ulcer that is refractory to treatment, or active GI bleeding within 6 months prior to enrollment * Patients with Vp3 and Vp4 portal vein thrombosis on baseline imaging are excluded
References
Publications (2)
- DERIVEDSangro B, Kudo M, Erinjeri JP, Qin S, Ren Z, Chan SL, Arai Y, Heo J, Mai A, Escobar J, Lopez Chuken YA, Yoon JH, Tak WY, Breder VV, Suttichaimongkol T, Bouattour M, Lin SM, Peron JM, Nguyen QT, Yan L, Chiu CF, Santos FA, Veluvolu A, Thungappa SC, Matos M, Zotkiewicz M, Udoye SI, Kurland JF, Cohen GJ, Lencioni R; EMERALD-1 Investigators. Durvalumab with or without bevacizumab with transarterial chemoembolisation in hepatocellular carcinoma (EMERALD-1): a multiregional, randomised, double-blind, placebo-controlled, phase 3 study. Lancet. 2025 Jan 18;405(10474):216-232. doi: 10.1016/S0140-6736(24)02551-0. Epub 2025 Jan 8. PMID 39798579
- DERIVEDKloeckner R, Galle PR, Bruix J. Local and Regional Therapies for Hepatocellular Carcinoma. Hepatology. 2021 Jan;73 Suppl 1:137-149. doi: 10.1002/hep.31424. Epub 2020 Nov 6. No abstract available. PMID 32557715