Back to resultsEvaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC (EMERALD-3)
Primary Purpose
Hepatocellular Carcinoma
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tremelimumab
Durvalumab
Transarterial Chemoembolization (TACE)
Lenvatinib
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Locoregional HCC, Durvalumab, Tremelimumab, Lenvatinib, TACE, Liver Cancer
Eligibility 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:
- 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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Arm A
Arm B
Arm C
Arm Description
Tremelimumab, Durvalumab and Lenvatinib in combination with Transarterial Chemoembolization (TACE)
Tremelimumab and Durvalumab in combination with Transarterial Chemoemobolization (TACE)
Transarterial Chemoembolization (TACE)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05301842
Brief Title
Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC
Acronym
EMERALD-3
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
February 26, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular Carcinoma, Locoregional HCC, Durvalumab, Tremelimumab, Lenvatinib, TACE, Liver Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Open-label
Allocation
Randomized
Enrollment
725 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
Tremelimumab, Durvalumab and Lenvatinib in combination with Transarterial Chemoembolization (TACE)
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Tremelimumab and Durvalumab in combination with Transarterial Chemoemobolization (TACE)
Arm Title
Arm C
Arm Type
Active Comparator
Arm Description
Transarterial Chemoembolization (TACE)
Intervention Type
Drug
Intervention Name(s)
Tremelimumab
Other Intervention Name(s)
MEDI1123
Intervention Description
Tremelimumab IV (intravenous)
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Other Intervention Name(s)
MEDI4736
Intervention Description
Durvalumab IV (intravenous)
Intervention Type
Procedure
Intervention Name(s)
Transarterial Chemoembolization (TACE)
Other Intervention Name(s)
DEB-TACE and cTACE
Intervention Description
TACE (chemo and embolic agent injection into the hepatic artery)
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Other Intervention Name(s)
Lenvima
Intervention Description
Lenvatinib (oral)
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) for Arm A vs Arm C
Description
PFS is defined as time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause
Time Frame
Approximately 5 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS) for Arm A vs Arm C
Description
OS is defined as the time from the date of randomization until death due to any cause
Time Frame
Approximately 5 years
Title
Progression Free Survival (PFS) for Arm B vs Arm C
Description
PFS is defined as time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause
Time Frame
Approximately 5 years
Title
Overall Survival (OS) for Arm B vs Arm C
Description
OS is defined as the time from the date of randomization until death due to any cause
Time Frame
Approximately 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36607
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Yuma
State/Province
Arizona
ZIP/Postal Code
85364
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Brasilia
ZIP/Postal Code
71681-603
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Niterói
ZIP/Postal Code
24020-096
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santa Maria
ZIP/Postal Code
97015-450
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santo Andre
ZIP/Postal Code
09060-650
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
São Paulo
ZIP/Postal Code
04014-002
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Vitória
ZIP/Postal Code
29043-272
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toronto
State/Province
CA
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100069
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changchun
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fuzhou
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fuzhou
ZIP/Postal Code
350011
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Haikou
ZIP/Postal Code
570311
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Harbin
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hefei
ZIP/Postal Code
230031
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lanzhou
ZIP/Postal Code
730030
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lishui
ZIP/Postal Code
323000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nanchang
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210002
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nantong
ZIP/Postal Code
226361
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Neijiang
ZIP/Postal Code
641000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Suzhou
ZIP/Postal Code
215004
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300170
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Urumqi
ZIP/Postal Code
830000
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Wenzhou
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430010
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430010
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Xi'an
ZIP/Postal Code
710000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450000
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zhuhai
ZIP/Postal Code
519000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Cairo
ZIP/Postal Code
11451
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Luxor
ZIP/Postal Code
85863
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Mansoura
ZIP/Postal Code
7650001
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
New Cairo
ZIP/Postal Code
11566
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Shebeen El Kom
ZIP/Postal Code
32511
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Clichy
ZIP/Postal Code
92110
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Creteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
MONTPELLIER Cedex 5
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nantes cedex 1
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nice
ZIP/Postal Code
06200
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hamburg
ZIP/Postal Code
22291
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ahmedabad
ZIP/Postal Code
380052
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ahmedabad
ZIP/Postal Code
380060
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Anand
ZIP/Postal Code
388001
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangalore
ZIP/Postal Code
560027
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangalore
ZIP/Postal Code
560092
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gurgaon
ZIP/Postal Code
122002
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gurugram
ZIP/Postal Code
122001
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hyderabad
ZIP/Postal Code
500032
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
JAipur
ZIP/Postal Code
302022
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kolkata
ZIP/Postal Code
700099
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ludhiana
ZIP/Postal Code
141001
Country
India
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Ludhiana
ZIP/Postal Code
141001
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Mumbai
ZIP/Postal Code
400012
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Nagpur
ZIP/Postal Code
440001
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110 085
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110005
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rishikesh
ZIP/Postal Code
249203
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tricase
ZIP/Postal Code
73039
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
810-8563
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hiroshima-shi
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kashihara-shi
ZIP/Postal Code
634-8522
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kashiwa
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kumamoto-shi
ZIP/Postal Code
860-8556
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mitaka-shi
ZIP/Postal Code
181-8611
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Morioka-shi
ZIP/Postal Code
028-3695
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Musashino-shi
ZIP/Postal Code
180-8610
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Okayama-shi
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
543-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Osakasayama-shi
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sapporo-shi
ZIP/Postal Code
006-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sendai-shi
ZIP/Postal Code
980-0873
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sunto-gun
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tokushima-shi
ZIP/Postal Code
770-8503
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tsu-shi
ZIP/Postal Code
514-8507
Country
Japan
Individual Site Status
Suspended
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Daegu
ZIP/Postal Code
42601
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jung-gu
ZIP/Postal Code
41944
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
George Town
ZIP/Postal Code
10450
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kuching
ZIP/Postal Code
93586
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Puncak Alam
ZIP/Postal Code
42300
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Selangor
ZIP/Postal Code
62250
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guadalajara, Jalisco
ZIP/Postal Code
44280
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
México
ZIP/Postal Code
1400
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Luis Potosí
ZIP/Postal Code
78209
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tuxtla Gutierrez
ZIP/Postal Code
29090
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Research Site
City
Davao City
ZIP/Postal Code
8000
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Research Site
City
Makati
ZIP/Postal Code
1229
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Research Site
City
Manila
ZIP/Postal Code
1003
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pasig City
ZIP/Postal Code
1600
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Research Site
City
Quezon City
ZIP/Postal Code
1112
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Vila Real
ZIP/Postal Code
5000-508
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Hato Rey Central
ZIP/Postal Code
00917
Country
Puerto Rico
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
143442
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Ar Riyāḑ
ZIP/Postal Code
11426
Country
Saudi Arabia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Dammam
ZIP/Postal Code
31444
Country
Saudi Arabia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Jeddah
ZIP/Postal Code
22384
Country
Saudi Arabia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Riyadh
ZIP/Postal Code
12713
Country
Saudi Arabia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Sebastian
ZIP/Postal Code
20014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tainan City
ZIP/Postal Code
70403
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
TAIWAN
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10210
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10300
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Phisanulok
ZIP/Postal Code
65000
Country
Thailand
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Ha Noi
ZIP/Postal Code
100000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hcmc
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hcmc
ZIP/Postal Code
70000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Learn more about this trial
Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC
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