Hepatocellular CarcinomaPhase 3EMERALD-3NCT05301842
Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC
A Phase 3 study testing Tremelimumab, Durvalumab and Transarterial Chemoembolization (TACE) in people with Hepatocellular Carcinoma, run by AstraZeneca at 171 sites in 22 countries.
Trial summary
A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Tremelimumab, Durvalumab and Transarterial Chemoembolization (TACE)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 760 participants
- Where
- 171 sitesin 22 countries
- Study dates
- 28 Mar 2022to 26 Feb 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
171 sites in 22 countries.
171 sites in 22 countries
China29 sites
Research Site
Beijing, 100021
Research Site
Beijing, 100069
Research Site
Beijing, 100142
Research Site
Changchun, 130021
Research Site
Changsha, 410013
Research Site
Chengdu, 610041
Research Site
Fuzhou, 350001
Research Site
Fuzhou, 350011
Research Site
Guangzhou, 510060
Research Site
Guangzhou, 510515
Research Site
Haikou, 570311
Research Site
Hangzhou, 310022
Research Site
Harbin, 150081
Research Site
Hefei, 230001
Research Site
Lanzhou, 730030
Research Site
Lishui, 323000
Research Site
Nanchang, 330006
Research Site
Nanjing, 210002
Research Site
Nantong, 226361
Research Site
Neijiang, 641000
Research Site
Shanghai, 200032
Research Site
Suzhou, 215004
Research Site
Tianjin, 300170
Research Site
Wenzhou, 325000
Research Site
Wuhan, 430010
Research Site
Wuhan, 430022
Research Site
Xi'an, 710000
Research Site
Zhengzhou, 450008
Research Site
Zhuhai, 519000
Japan19 sites
Research Site
Chūōku, 104-0045
Research Site
Fukuoka, 810-8563
Research Site
Hiroshima, 734-8551
Research Site
Kashihara-shi, 634-8522
Research Site
Kashiwa, 277-8577
Research Site
Kumamoto, 860-8556
Research Site
Mitaka-shi, 181-8611
Research Site
Morioka, 028-3695
Research Site
Musashino-shi, 180-8610
Research Site
Okayama, 700-8558
Research Site
Osaka, 543-8555
Research Site
Osaka, 545-8586
Research Site
Osakasayama-shi, 589-8511
Research Site
Sapporo, 006-8555
Research Site
Sendai, 981-0914
Research Site
Sunto-gun, 411-8777
Research Site
Tokushima, 770-8503
Research Site
Tsu, 514-8507
Research Site
Yokohama, 241-8515
Germany13 sites
Research Site
Bonn, 53127
Research Site
Chemnitz, 09116
Research Site
Dresden, 01307
Research Site
Düsseldorf, 40225
Research Site
Frankfurt, 60596
Research Site
Göttingen, 37075
Research Site
Hamburg, 22291
Research Site
Hanover, 30625
Research Site
Heidelberg, 69120
Research Site
Kiel, 24105
Research Site
Leipzig, 04103
Research Site
Magdeburg, 39120
Research Site
Ulm, 89081
United States12 sites
Research Site
Atlanta, Georgia, 30318
Research Site
Baltimore, Maryland, 21201
Research Site
Birmingham, Alabama, 35233
Research Site
Commack, New York, 11725
Research Site
Dallas, Texas, 75235
Research Site
Glendale, California, 91204
Research Site
Houston, Texas, 77030
Research Site
Memphis, Tennessee, 38104
Research Site
Mobile, Alabama, 36607
Research Site
New York, New York, 10029
Research Site
Santa Fe, New Mexico, 87505
Research Site
Yuma, Arizona, 85364
France10 sites
Research Site
Angers, 49933
Research Site
Clichy, 92110
Research Site
Créteil, 94010
Research Site
Montpellier, 34295
Research Site
Nantes, 44093
Research Site
Nice, 06200
Research Site
Paris, 75013
Research Site
Strasbourg, 67091
Research Site
Toulouse, 31059
Research Site
Vandœuvre-lès-Nancy, 54511
India10 sites
Research Site
Ahmedabad, 380054
Research Site
Ahmedabad, 380060
Research Site
Bangalore, 560027
Research Site
Delhi, 110029
Research Site
Hyderabad, 500032
Research Site
Jaipur, 302022
Research Site
Kolkata, 700099
Research Site
Mumbai, 400012
Research Site
New Delhi, 110 085
Research Site
New Delhi, 110005
Brazil9 sites
Research Site
Barretos, 14784-400
Research Site
Brasília, 71681-603
Research Site
Niterói, 24020-096
Research Site
Porto Alegre, 91350-200
Research Site
Rio de Janeiro, 20231-050
Research Site
Santa Maria, 97015-450
Research Site
Santo André, 09060-650
Research Site
São Paulo, 04014-002
Research Site
Vitória, 29043-272
Canada8 sites
Research Site
Calgary, Alberta, T2N 5G2
Research Site
Halifax, Nova Scotia, B3H 2Y9
Research Site
Kingston, Ontario, K7L 5P9
Research Site
Montreal, Quebec, H2X 3E4
Research Site
Montreal, Quebec, H4A 3J1
Research Site
Ottawa, Ontario, K1H 8L6
Research Site
Toronto, Ontario, M4N 3M5
Research Site
Toronto, Ontario, M5G 2M9
Italy7 sites
Research Site
Arezzo, 52100
Research Site
Florence, 50134
Research Site
Milan, 20132
Research Site
Milan, 20133
Research Site
Roma, 00128
Research Site
Rozzano, 20089
Research Site
Tricase, 73039
South Korea7 sites
Research Site
Busan, 49241
Research Site
Daegu, 42601
Research Site
Goyang-si, 10408
Research Site
Junggu, 41944
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 06351
Thailand7 sites
Research Site
Bangkok, 10210
Research Site
Bangkok, 10300
Research Site
Bangkok, 10400
Research Site
Bangkok, 10700
Research Site
Chiang Mai, 50200
Research Site
Hat Yai, 90110
Research Site
Khon Kaen, 40002
Taiwan6 sites
Research Site
Taichung, 40447
Research Site
Taichung, 40705
Research Site
Tainan, 70403
Research Site
Taipei, 100
Research Site
Taipei, TAIWAN
Research Site
Taoyuan, 333
Malaysia5 sites
Research Site
Bandar Puncak Alam, 42300
Research Site
George Town, 10450
Research Site
Kuala Lumpur, 59100
Research Site
Kuala Selangor, 62250
Research Site
Kuching, 93586
Philippines5 sites
Research Site
Davao City, 8000
Research Site
Makati, 1229
Research Site
Manila, 1003
Research Site
Pasig, 1600
Research Site
Quezon City, 1112
Spain5 sites
Research Site
Barcelona, 08036
Research Site
Córdoba, 14004
Research Site
Donostia / San Sebastian, 20014
Research Site
Madrid, 28007
Research Site
Madrid, 28034
Mexico4 sites
Research Site
Guadalajara, Jalisco, 44280
Research Site
México, 1400
Research Site
San Luis Potosí City, 78209
Research Site
Tuxtla Gutiérrez, 29090
Vietnam4 sites
Research Site
Hà Nội, 100000
Research Site
Hanoi, 100000
Research Site
Ho Chi Minh City, 700000
Research Site
Ho Chi Minh City, 70000
Egypt3 sites
Research Site
Al Mansurah, 7650001
Research Site
Cairo, 11451
Research Site
Shebeen El Kom, 32511
Portugal2 sites
Research Site
Lisbon, 1649-035
Research Site
Vila Real, 5000-508
Puerto Rico2 sites
Research Site
Hato Rey Central, 00917
Research Site
San Juan, 00927
Saudi Arabia2 sites
Research Site
Jeddah, 22384
Research Site
Riyadh, 12713
About this study
Official title: 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)
A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma
Read the detailed description
This is a Phase III, parallel, randomized, open-label, sponsor-blinded, 3-arm, multicenter, international study assessing the efficacy and safety of durvalumab + tremelimumab + TACE with or without lenvatinib compared with TACE alone in participants with locoregional HCC not amenable to curative therapy (eg, surgical resection, transplantation, or ablation).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Tremelimumab, Durvalumab, Transarterial Chemoembolization (TACE), Lenvatinib
- Keywords
- Hepatocellular Carcinoma, Locoregional HCC, Durvalumab, Tremelimumab, Lenvatinib, TACE, Liver Cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TremelimumabDrug
Also called MEDI1123
Tremelimumab IV (intravenous)
DurvalumabDrug
Also called MEDI4736
Durvalumab IV (intravenous)
Transarterial Chemoembolization (TACE)Procedure or surgery
Also called DEB-TACE and cTACE
TACE (chemo and embolic agent injection into the hepatic artery)
LenvatinibDrug
Also called Lenvima
Lenvatinib (oral)
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Tremelimumab, Durvalumab and Lenvatinib in combination with Transarterial Chemoembolization (TACE) Receives: Drug: Tremelimumab; Drug: Durvalumab; Procedure: Transarterial Chemoembolization (TACE); Drug: Lenvatinib |
| Arm B | Experimental | Tremelimumab and Durvalumab in combination with Transarterial Chemoemobolization (TACE) Receives: Drug: Tremelimumab; Drug: Durvalumab; Procedure: Transarterial Chemoembolization (TACE) |
| Arm C | Active comparator | Transarterial Chemoembolization (TACE) Receives: Procedure: Transarterial Chemoembolization (TACE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) for Arm A vs Arm C
PFS is defined as time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause
Measured: Approximately 5 years
Secondary outcomes (3)
Overall Survival (OS) for Arm A vs Arm C
OS is defined as the time from the date of randomization until death due to any cause
Measured: Approximately 5 years
Progression Free Survival (PFS) for Arm B vs Arm C
PFS is defined as time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause
Measured: Approximately 5 years
Overall Survival (OS) for Arm B vs Arm C
OS is defined as the time from the date of randomization until death due to any cause
Measured: Approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start28 Mar 2022
- Primary completion23 Feb 2026
- Study completion26 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 760 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301842
- Sponsor's protocol ID
- D910VC00001
- Other IDs
- 2023-508701-24-00, 2021-003822-54, 2023
- Acronym
- EMERALD-3
- Status last verified
- Oct 2026
- First submitted
- 21 Mar 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Publications
Kudo 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.
PubMed 42636832
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05301842
- Acronym / sponsor ID
- EMERALD-3 / D910VC00001
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Locoregional HCC, Durvalumab, Tremelimumab, Lenvatinib, TACE, Liver Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 760 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 23 Feb 2026 (actual)
- Study completion
- 26 Feb 2027 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma
Detailed description
This is a Phase III, parallel, randomized, open-label, sponsor-blinded, 3-arm, multicenter, international study assessing the efficacy and safety of durvalumab + tremelimumab + TACE with or without lenvatinib compared with TACE alone in participants with locoregional HCC not amenable to curative therapy (eg, surgical resection, transplantation, or ablation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Tremelimumab, Drug: Durvalumab, Procedure: Transarterial Chemoembolization (TACE), Drug: LenvatinibTremelimumab, Durvalumab and Lenvatinib in combination with Transarterial Chemoembolization (TACE) |
| Arm B | Experimental | Drug: Tremelimumab, Drug: Durvalumab, Procedure: Transarterial Chemoembolization (TACE)Tremelimumab and Durvalumab in combination with Transarterial Chemoemobolization (TACE) |
| Arm C | Active comparator | Procedure: Transarterial Chemoembolization (TACE)Transarterial Chemoembolization (TACE) |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TremelimumabAlso: MEDI1123Tremelimumab IV (intravenous) | Drug | Arm A, Arm B |
| DurvalumabAlso: MEDI4736Durvalumab IV (intravenous) | Drug | Arm A, Arm B |
| Transarterial Chemoembolization (TACE)Also: DEB-TACE and cTACETACE (chemo and embolic agent injection into the hepatic artery) | Procedure or surgery | Arm A, Arm B, Arm C |
| LenvatinibAlso: LenvimaLenvatinib (oral) | Drug | Arm A |
Primary outcome
Progression Free Survival (PFS) for Arm A vs Arm C
Time frame: Approximately 5 years
PFS is defined as time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause
3 secondary outcomes
Overall Survival (OS) for Arm A vs Arm C
Time frame: Approximately 5 years
Progression Free Survival (PFS) for Arm B vs Arm C
Time frame: Approximately 5 years
Overall Survival (OS) for Arm B vs Arm C
Time frame: Approximately 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Derived from this study: PubMed 42636832Kudo 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.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
171 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tremelimumab, Durvalumab and Transarterial Chemoembolization (TACE) in people with Hepatocellular Carcinoma, run by AstraZeneca at 171 sites in 22 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 171 sites in China, Japan, Germany, United States, France and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) for Arm A vs Arm C (time frame: Approximately 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05301842, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.