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Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma (HIMALAYA)

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ClinicalTrials.gov Identifier: NCT03298451
Recruitment Status : Active, not recruiting
First Posted : October 2, 2017
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
This is a randomized, open-label, multi-center, global, Phase III study to assess the efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC. The patients cannot be eligible for locoregional therapy.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Durvalumab Drug: Tremelimumab (Regimen 1) Drug: Tremelimumab (Regimen 2) Drug: Sorafenib Drug: Durvalumab (Regimen 1) Drug: Durvalumab (Regimen 2) Phase 3

Detailed Description:

The study population includes patients 18 years of age or older with advanced HCC, Barcelona Clinic Liver Cancer stage B not eligible for locoregional therapy or stage C, and Child-Pugh A classification liver disease. Patients must not have received any prior systemic therapy for unresectable HCC.

Patients in all treatment arms may continue receiving their originally assigned treatment, at the Investigator's discretion, until progression

Patients in all arms with confirmed PD who, in the Investigator's opinion, continue to receive benefit from their assigned treatment and meet the criteria for treatment in the setting of PD may continue to receive their assigned treatment.

If a patient discontinues study drug(s) due to disease progression, the patient will enter survival follow-up. Patients who have discontinued treatment due to toxicity or symptomatic deterioration or who have commenced subsequent anticancer therapy, will have tumor assessments until confirmed PD and will be followed for survival.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Actual Study Start Date : October 11, 2017
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: Arm 1
Durvalumab
Drug: Durvalumab
Durvalumab IV (intravenous infusion).
Other Name: MEDI4736

Experimental: Arm 2
Durvalumab in combination with tremelimumab (Regimen 1)
Drug: Tremelimumab (Regimen 1)
Tremelimumab IV (intravenous infusion).

Drug: Durvalumab (Regimen 1)
Durvalumab IV (intravenous infusion).

Experimental: Arm 3
Durvalumab in combination with tremelimumab (Regimen 2)
Drug: Tremelimumab (Regimen 2)
Tremelimumab IV (intravenous infusion).

Drug: Durvalumab (Regimen 2)
Durvalumab IV (intravenous infusion).

Active Comparator: Arm 4
Sorafenib
Drug: Sorafenib
Sorafenib, as per standard of care




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From the date of randomization until death due to any cause, assessed up to 4 years. ]

Secondary Outcome Measures :
  1. Time to Progression (TTP) [ Time Frame: From randomization until objective tumor progression, assessed up to 4 years. ]
  2. Progression-free survival (PFS) [ Time Frame: From date of randomization until the date of objective disease progression or death, assessed up to 4 years. ]
  3. Objective response rate (ORR) [ Time Frame: Until progression, assessed up to 4 years. ]
  4. Disease control rate (DCR) [ Time Frame: Until progression, assessed up to 4 years. ]
  5. Duration of response (DoR) [ Time Frame: From the date of first documented response (RECIST 1.1.) until the first date of documented progression or death in the absence of disease progression, assessed up to 4 years. ]

Other Outcome Measures:
  1. Adverse events [ Time Frame: From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 4 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • HCC based on histopathological confirmation
  • No prior systemic therapy for HCC
  • Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C
  • Child-Pugh Score class A
  • ECOG performance status of 0 or 1 at enrollment

Exclusion criteria

  • Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy
  • Clinically meaningful ascites
  • Main portal vein tumor thrombosis
  • Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 12 months
  • HBV and HVC co-infection, or HBV and Hep D co-infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03298451


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United States, California
Research Site
Los Angeles, California, United States, 900048
Research Site
Orange, California, United States, 92868
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San Francisco, California, United States, 94143
United States, District of Columbia
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Washington, District of Columbia, United States, 20007
United States, Florida
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Fort Myers, Florida, United States, 33916
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Jacksonville, Florida, United States, 32224
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Saint Petersburg, Florida, United States, 33705
United States, Kansas
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Westwood, Kansas, United States, 66205
United States, Maryland
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Baltimore, Maryland, United States, 21287
United States, Massachusetts
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Boston, Massachusetts, United States, 02215
United States, Michigan
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Ann Arbor, Michigan, United States, 48109
United States, Minnesota
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Rochester, Minnesota, United States, 55905
United States, New York
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New York, New York, United States, 10065
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Stony Brook, New York, United States, 11795
United States, North Carolina
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Charlotte, North Carolina, United States, 28204
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Durham, North Carolina, United States, 27710
United States, Oregon
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Portland, Oregon, United States, 97213
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
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Philadelphia, Pennsylvania, United States, 19140
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Pittsburgh, Pennsylvania, United States, 15232-1301
United States, Tennessee
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Germantown, Tennessee, United States, 38138
United States, Texas
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Dallas, Texas, United States, 75216
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Dallas, Texas, United States, 75390
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Houston, Texas, United States, 77030
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Houston, Texas, United States, 77090
United States, Utah
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Murray, Utah, United States, 84107
Brazil
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Barretos, Brazil, 14784-400
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Curitiba, Brazil, 80810-050
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Curitiba, Brazil, 81520-060
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Florianópolis, Brazil, 88034-000
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Porto Alegre, Brazil, 90035-003
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Porto Alegre, Brazil, 90610-000
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Porto Alegre, Brazil, 91350-200
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Ribeirão Preto, Brazil, 14021-636
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Rio de Janeiro, Brazil, 20231-050
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Rio de Janeiro, Brazil, 22793-080
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Santo Andre, Brazil, 09060-870
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Santo Andre, Brazil, 09080-110
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Sao Paulo, Brazil, 01246-000
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São José do Rio Preto, Brazil, 15090-000
Canada, Alberta
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Calgary, Alberta, Canada, T2N 4N2
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Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
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Hamilton, Ontario, Canada, L8V 5C2
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Kingston, Ontario, Canada, K7L 2V7
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London, Ontario, Canada, N6A 4L6
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Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
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Montreal, Quebec, Canada, H2X 3E4
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Sherbrooke, Quebec, Canada, J1H 5N4
Canada
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Quebec, Canada, G1R 2J6
China
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Beijing, China, 100006
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Beijing, China, 100021
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Beijing, China, 100039
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Beijing, China, 100050
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Beijing, China, 100142
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Beijing, China, 100730
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Beijing, China
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Changchun, China, 130012
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Changchun, China, 130021
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Changsha, China, 410013
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Chengdu, China, 610041
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Dalian, China, 116011
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Fuzhou, China, 350025
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Guangzhou, China, 510010
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Guangzhou, China, 510080
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Guangzhou, China, 510515
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Hangzhou, China, 310022
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Harbin, China, 150081
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Hefei, China, 230601
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Nanjing, China, 210002
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Nanjing, China, 210009
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Nanning, China, 530021
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Shanghai, China, 200001
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Shanghai, China, 200032
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Wuhan, China, CN-430030
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Xi'an, China, 710032
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Xi'an, China, 710038
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Xian, China, 710061
France
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Clichy, France, 92110
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Lille, France, 59037
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Marseille cedex 09, France, 13273
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MONTPELLIER Cedex 5, France, 34295
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Nantes, France, 44093
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Nice Cedex 3, France, 06202
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Pessac, France, 33604
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Poitiers, France, 86021
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Reims, France, 51092
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Rouen Cedex, France, 76031
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Saint Etienne Cedex 2, France, 42055
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Toulouse Cedex 9, France, 31059
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Vandoeuvre Les Nancy, France, 54511
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Villejuif, France, 94800
Germany
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Aachen, Germany, 52074
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Essen, Germany, 45122
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Hannover, Germany, 30623
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Heidelberg, Germany, 69120
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Köln, Germany, 50937
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Leipzig, Germany, 04103
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Mainz, Germany, 55131
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München, Germany, 81377
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Tuebingen, Germany, 72076
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Ulm, Germany, 89081
Hong Kong
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Hong Kong, Hong Kong
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King's Park, Hong Kong, 150001
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Shatin, Hong Kong
India
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Bangalore, India, 560068
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Bhubaneswar, India, 751007
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Chennai, India, 600035
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Gurgaon, India, 122001
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Hubli, India, 580025
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Hyderabad, India, 500034
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Karamsad, India, 388325
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Mumbai, India, 400 012
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Mumbai, India, 400053
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Nasik, India, 422002
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New Delhi, India, 110063
Italy
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Benevento, Italy, 82100
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Meldola, Italy, 47014
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Milano, Italy, 20132
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Napoli, Italy, 80131
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Perugia, Italy, 06132
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Pisa, Italy, 56100
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Roma, Italy, 00168
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Rozzano, Italy, 20089
Japan
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Bunkyo-ku, Japan, 113-8655
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Chiba-shi, Japan, 260-8677
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Fukuoka-shi, Japan, 810-8563
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Hiroshima-shi, Japan, 734-8551
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Iizuka-shi, Japan, 820-8505
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Kanazawa-shi, Japan, 920-8641
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Koto-ku, Japan, 135-8550
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Kumamoto-shi, Japan, 860-8556
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Kurume-shi, Japan, 830-0011
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Matsuyama-shi, Japan, 791-0280
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Mitaka-shi, Japan, 181-8611
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Morioka-shi, Japan, 020-8505
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Musashino-shi, Japan, 180-8610
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Nagoya-shi, Japan, 464-8681
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Ogaki-shi, Japan, 503-8502
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Okayama-shi, Japan, 700-8558
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Osaka-shi, Japan, 534-0021
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Osaka-shi, Japan, 541-8567
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Osaka-shi, Japan, 543-8555
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Osaka-shi, Japan, 545-8586
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Osakasayama-shi, Japan, 589-8511
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Saga-shi, Japan, 840-8571
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Sapporo-shi, Japan, 006-8555
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Sunto-gun, Japan, 411-8777
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Tsu-shi, Japan, 514-8507
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Yokohama-shi, Japan, 232-0024
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Yokohama-shi, Japan, 241-8515
Korea, Republic of
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Busan, Korea, Republic of, 49241
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Daegu, Korea, Republic of, 41944
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Gyeonggi-do, Korea, Republic of, 10408
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Seongnam, Korea, Republic of, 468-802
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Seoul, Korea, Republic of, 03080
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Seoul, Korea, Republic of, 03722
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Seoul, Korea, Republic of, 05505
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Seoul, Korea, Republic of, 06351
Russian Federation
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Kuzmolovsky, Russian Federation, 188663
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Moscow, Russian Federation, 115478
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Moscow, Russian Federation, 125367
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Murmansk, Russian Federation, 183047
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Nizhniy Novgorod, Russian Federation, 603001
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Novosibirsk, Russian Federation, 630007
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Obninsk, Russian Federation, 249036
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Omsk, Russian Federation, 644013
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Saint Petersburg, Russian Federation, 195271
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Saint Petersburg, Russian Federation, 198255
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Saint-Petersburg, Russian Federation, 191015
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Ufa, Russian Federation, 450054
Spain
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Barcelona, Spain, 08036
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Madrid, Spain, 28034
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Madrid, Spain, 28041
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Oviedo, Spain, 33011
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Pamplona, Spain, 31008
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Santander, Spain, 39008
Taiwan
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Kaohsiung Hsien, Taiwan, 83342
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Putzu City, Taiwan, 0613
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Taichung, Taiwan, 404
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Tainan, Taiwan, 704
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Tainan, Taiwan, 710
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Taipei, Taiwan, 10048
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Taipei, Taiwan, 11217
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Taipei, Taiwan
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Taoyuan, Taiwan, 00333
Thailand
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Bangkok, Thailand, 10210
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Bangkok, Thailand, 10330
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Bangkok, Thailand, 10400
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Chiang Mai, Thailand, 50200
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Khon Kaen, Thailand, 40002
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Phitsanulok, Thailand, 65000
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Songkla, Thailand, 90110
Ukraine
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Dnipro, Ukraine, 49102
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Ivano-Frankivsk, Ukraine, 76018
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Kharkiv, Ukraine, 61070
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Kirovograd, Ukraine, 25006
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Kyiv, Ukraine, 03022
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Lviv, Ukraine, 79031
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Odesa, Ukraine, 65055
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Uzhhorod, Ukraine, 88000
Vietnam
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Hanoi City, Vietnam
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Hanoi, Vietnam, 100000
Research Site
Ho Chi Minh, Vietnam, 700000
Sponsors and Collaborators
AstraZeneca

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03298451     History of Changes
Other Study ID Numbers: D419CC00002
First Posted: October 2, 2017    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Hepatocellular Carcinoma Non-Resectable
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Durvalumab
Tremelimumab
Antibodies, Monoclonal
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Immunologic Factors
Physiological Effects of Drugs