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First Line Hepato Cellular Carcinoma (HCC) (BRISK FL)

Primary Purpose

Hepato Cellular Carcinoma (HCC)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Brivanib
Placebo
Sorafenib
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepato Cellular Carcinoma (HCC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • Histologic or cytologic confirmed diagnosis of HCC.
  • Advanced HCC: disease not eligible for surgical and/or locoregional therapies OR progressive disease after surgical and/or locoregional therapies
  • Child-Pugh Class A
  • ECOG performance status 0-1
  • Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

  • Prior use of any systemic anti-cancer chemotherapy, immunotherapy or molecular targeted agents for HCC
  • History of active cardiac disease
  • Thrombotic or embolic events within the past 6 months (except HCC tumor thrombus)
  • Any other hemorrhage/bleeding event >= CTCAE Grade 3 within 8 weeks except for esophageal or gastric varices
  • Inability to swallow tablets or untreated malabsorption syndrome

Sites / Locations

  • Mayo Clinic Arizona
  • Univ Of Ark For Med Sci
  • Agajanian Institute Of Hematology And Oncology
  • Sharp Clinical Oncology Research
  • Va Ct Healthcare System
  • Medical Specialists Of Palm Beaches
  • James Graham Brown Cancer Center
  • 3912 Taubman Center
  • Karmanos Cancer Institute
  • Thomas Jefferson Univ.
  • Mcguire Dvamc
  • University Of Wisconsin
  • Local Institution
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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Brivanib

Sorafenib

Arm Description

Outcomes

Primary Outcome Measures

To compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic treatment

Secondary Outcome Measures

To compare the time to progression (TTP) (investigator assessed using modified RECIST criteria for HCC
To compare the investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST criteria for HCC
To determine duration of response, duration of disease control, and time to response (TTR)
To assess the safety profile of brivanib and sorafenib
To explore PK and exposure-response in the study population
To compare time to symptomatic progression
To compare health-related quality of life

Full Information

First Posted
March 9, 2009
Last Updated
October 14, 2016
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00858871
Brief Title
First Line Hepato Cellular Carcinoma (HCC)
Acronym
BRISK FL
Official Title
A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Versus Sorafenib as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepato Cellular Carcinoma (HCC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1714 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brivanib
Arm Type
Active Comparator
Arm Title
Sorafenib
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Brivanib
Other Intervention Name(s)
BMS-582664
Intervention Description
Tablets, Oral, 800 mg, Once Daily, Until disease progression or unacceptable toxicity
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules, Oral, twice Daily, Until disease progression or unacceptable toxicity
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
Capsules, Oral, 800 mg, twice daily, Until disease progression or unacceptable toxicity
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets, Oral, Once Daily, Until disease progression or unacceptable toxicity
Primary Outcome Measure Information:
Title
To compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic treatment
Time Frame
Survival will be assessed continuously
Secondary Outcome Measure Information:
Title
To compare the time to progression (TTP) (investigator assessed using modified RECIST criteria for HCC
Time Frame
Every 6 weeks
Title
To compare the investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST criteria for HCC
Time Frame
Every 6 weeks
Title
To determine duration of response, duration of disease control, and time to response (TTR)
Time Frame
Every 6 weeks
Title
To assess the safety profile of brivanib and sorafenib
Time Frame
Every 6 weeks
Title
To explore PK and exposure-response in the study population
Time Frame
Every 6 weeks
Title
To compare time to symptomatic progression
Time Frame
Every 6 weeks
Title
To compare health-related quality of life
Time Frame
Every 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: Histologic or cytologic confirmed diagnosis of HCC. Advanced HCC: disease not eligible for surgical and/or locoregional therapies OR progressive disease after surgical and/or locoregional therapies Child-Pugh Class A ECOG performance status 0-1 Adequate hematologic, hepatic, and renal function Exclusion Criteria: Prior use of any systemic anti-cancer chemotherapy, immunotherapy or molecular targeted agents for HCC History of active cardiac disease Thrombotic or embolic events within the past 6 months (except HCC tumor thrombus) Any other hemorrhage/bleeding event >= CTCAE Grade 3 within 8 weeks except for esophageal or gastric varices Inability to swallow tablets or untreated malabsorption syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Univ Of Ark For Med Sci
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Agajanian Institute Of Hematology And Oncology
City
Downey
State/Province
California
ZIP/Postal Code
90241
Country
United States
Facility Name
Sharp Clinical Oncology Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Va Ct Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Facility Name
Medical Specialists Of Palm Beaches
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Facility Name
James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
3912 Taubman Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Thomas Jefferson Univ.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Mcguire Dvamc
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
University Of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Local Institution
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1221
Country
Argentina
Facility Name
Local Institution
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
C1264AAA
Country
Argentina
Facility Name
Local Institution
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Local Institution
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Local Institution
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Local Institution
City
Westmead Nsw
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Local Institution
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Local Institution
City
Prahan
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Local Institution
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Local Institution
City
Salvador - Ba
State/Province
Bahia
ZIP/Postal Code
40050-410
Country
Brazil
Facility Name
Local Institution
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41950-610
Country
Brazil
Facility Name
Local Institution
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60430-230
Country
Brazil
Facility Name
Local Institution
City
Goiania
State/Province
Goias
ZIP/Postal Code
74075-040
Country
Brazil
Facility Name
Local Institution
City
Divinopolis
State/Province
Minas Gerais
ZIP/Postal Code
35500-249
Country
Brazil
Facility Name
Local Institution
City
Curitiba
State/Province
Parana
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90050-170
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Local Institution
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Local Institution
City
Jau
State/Province
Sao Paulo
ZIP/Postal Code
17210-080
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
01323-010
Country
Brazil
Facility Name
Local Institution
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Local Institution
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Local Institution
City
London
State/Province
Ontario
ZIP/Postal Code
N6A A5
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada
Facility Name
Local Institution
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Local Institution
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Local Institution
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Local Institution
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
Local Institution
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Local Institution
City
Guanzhou
State/Province
Guangdong
ZIP/Postal Code
510010
Country
China
Facility Name
Local Institution
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Local Institution
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Local Institution
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Local Institution
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Facility Name
Local Institution
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
Local Institution
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Local Institution
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
Local Institution
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Facility Name
Local Institution
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
Facility Name
Local Institution
City
Xi An
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Facility Name
Local Institution
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Local Institution
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Local Institution
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
130016
Country
China
Facility Name
Local Institution
City
Brno
ZIP/Postal Code
656 53
Country
Czech Republic
Facility Name
Local Institution
City
Prague 5
ZIP/Postal Code
150 06
Country
Czech Republic
Facility Name
Local Institution
City
Praha 2
ZIP/Postal Code
128 08
Country
Czech Republic
Facility Name
Local Institution
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Local Institution
City
Clichy Cedex
ZIP/Postal Code
92118
Country
France
Facility Name
Local Institution
City
Creteil Cedex
ZIP/Postal Code
94010
Country
France
Facility Name
Local Institution
City
Grenoble Cedex 09
ZIP/Postal Code
38043
Country
France
Facility Name
Local Institution
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Local Institution
City
Lyon Cedex 04
ZIP/Postal Code
69317
Country
France
Facility Name
Local Institution
City
Marseille Cedex 05
ZIP/Postal Code
13385
Country
France
Facility Name
Local Institution
City
Marseille Cedex 9
ZIP/Postal Code
13009
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Local Institution
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Local Institution
City
Vandoeuvre Cedex
ZIP/Postal Code
54511
Country
France
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Local Institution
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Local Institution
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Local Institution
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Local Institution
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Local Institution
City
Hong Kong
ZIP/Postal Code
8525
Country
Hong Kong
Facility Name
Local Institution
City
Shatin
ZIP/Postal Code
8520
Country
Hong Kong
Facility Name
Local Institution
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500082
Country
India
Facility Name
Local Institution
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682304
Country
India
Facility Name
Local Institution
City
Trivandrum
State/Province
Kerala
ZIP/Postal Code
695011
Country
India
Facility Name
Local Institution
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Local Institution
City
Ahmedabad
ZIP/Postal Code
380009
Country
India
Facility Name
Local Institution
City
Chennai
ZIP/Postal Code
600006
Country
India
Facility Name
Local Institution
City
Coimbatore
ZIP/Postal Code
641037
Country
India
Facility Name
Local Institution
City
Hyderabad
ZIP/Postal Code
500024
Country
India
Facility Name
Local Institution
City
Kolkata
ZIP/Postal Code
700 053
Country
India
Facility Name
Local Institution
City
Kolkata
ZIP/Postal Code
700054
Country
India
Facility Name
Local Institution
City
Mumbai
ZIP/Postal Code
400012
Country
India
Facility Name
Local Institution
City
Mumbai
ZIP/Postal Code
400036
Country
India
Facility Name
Local Institution
City
New Delhi
ZIP/Postal Code
110 070
Country
India
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Local Institution
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Local Institution
City
Torrette -Ancona
ZIP/Postal Code
60020
Country
Italy
Facility Name
Local Institution
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-0882
Country
Japan
Facility Name
Local Institution
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
Local Institution
City
Kanazawa-Shi
State/Province
Ishikawa
ZIP/Postal Code
9208641
Country
Japan
Facility Name
Local Institution
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
2138587
Country
Japan
Facility Name
Local Institution
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Local Institution
City
Tsu-shi
State/Province
MIE
ZIP/Postal Code
5148507
Country
Japan
Facility Name
Local Institution
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
7000082
Country
Japan
Facility Name
Local Institution
City
Higashinari-ku
State/Province
Osaka
ZIP/Postal Code
5378511
Country
Japan
Facility Name
Local Institution
City
Osaka-Sayama City
State/Province
Osaka
ZIP/Postal Code
5890014
Country
Japan
Facility Name
Local Institution
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
Local Institution
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
5438555
Country
Japan
Facility Name
Local Institution
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
5458586
Country
Japan
Facility Name
Local Institution
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Local Institution
City
Chuo-Ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Local Institution
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-0001
Country
Japan
Facility Name
Local Institution
City
Musashino-shi
State/Province
Tokyo
ZIP/Postal Code
180-0023
Country
Japan
Facility Name
Local Institution
City
Shimonoseki-shi
State/Province
Yamaguchi
ZIP/Postal Code
7500061
Country
Japan
Facility Name
Local Institution
City
Nishinomiya-shi
ZIP/Postal Code
6638501
Country
Japan
Facility Name
Local Institution
City
Busan
ZIP/Postal Code
609-735
Country
Korea, Republic of
Facility Name
Local Institution
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
Local Institution
City
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Local Institution
City
Kyunggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
137-040
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Local Institution
City
D.f.
State/Province
Distrito Federal
ZIP/Postal Code
06720
Country
Mexico
Facility Name
Local Institution
City
D.f.
State/Province
Distrito Federal
ZIP/Postal Code
14140
Country
Mexico
Facility Name
Local Institution
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Local Institution
City
Tlalpan
State/Province
Distrito Federal
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Local Institution
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Local Institution
City
Aguascalientes
ZIP/Postal Code
20234
Country
Mexico
Facility Name
Local Institution
City
Distrito Federal
ZIP/Postal Code
06760
Country
Mexico
Facility Name
Local Institution
City
Gdansk
ZIP/Postal Code
80952
Country
Poland
Facility Name
Local Institution
City
Gliwice
ZIP/Postal Code
44-101
Country
Poland
Facility Name
Local Institution
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Local Institution
City
San Juan
ZIP/Postal Code
00910
Country
Puerto Rico
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
115 478
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
115998
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
119992
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Local Institution
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Local Institution
City
Durban
State/Province
Kwa Zulu Natal
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Local Institution
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Local Institution
City
Observatory, Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Local Institution
City
Rondebosch
State/Province
Western Cape
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Local Institution
City
Santiago De Compostela
State/Province
A Coruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
Local Institution
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Local Institution
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Local Institution
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Local Institution
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Local Institution
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Local Institution
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
Local Institution
City
Tainan R.O.C.
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Local Institution
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Local Institution
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Local Institution
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Local Institution
City
Ankara
ZIP/Postal Code
06460
Country
Turkey
Facility Name
Local Institution
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Facility Name
Local Institution
City
Istanbul
Country
Turkey
Facility Name
Local Institution
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Local Institution
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Facility Name
Local Institution
City
Bristol
State/Province
Avon
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Local Institution
City
London
State/Province
Greater London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Local Institution
City
London
State/Province
Greater London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Local Institution
City
London
State/Province
Greater London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Local Institution
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Local Institution
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2TT
Country
United Kingdom
Facility Name
Local Institution
City
Leeds
State/Province
Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34052255
Citation
Kolamunnage-Dona R, Berhane S, Potts H, Williams EH, Tanner J, Janowitz T, Hoare M, Johnson P. Sorafenib is associated with a reduced rate of tumour growth and liver function deterioration in HCV-induced hepatocellular carcinoma. J Hepatol. 2021 Oct;75(4):879-887. doi: 10.1016/j.jhep.2021.05.015. Epub 2021 May 27.
Results Reference
derived
PubMed Identifier
23980084
Citation
Johnson PJ, Qin S, Park JW, Poon RT, Raoul JL, Philip PA, Hsu CH, Hu TH, Heo J, Xu J, Lu L, Chao Y, Boucher E, Han KH, Paik SW, Robles-Avina J, Kudo M, Yan L, Sobhonslidsuk A, Komov D, Decaens T, Tak WY, Jeng LB, Liu D, Ezzeddine R, Walters I, Cheng AL. Brivanib versus sorafenib as first-line therapy in patients with unresectable, advanced hepatocellular carcinoma: results from the randomized phase III BRISK-FL study. J Clin Oncol. 2013 Oct 1;31(28):3517-24. doi: 10.1200/JCO.2012.48.4410. Epub 2013 Aug 26.
Results Reference
derived
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

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First Line Hepato Cellular Carcinoma (HCC)

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