Clinical trial NCT01761266: A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-line Treatment of Participants With Unresectable Hepatocellular Carcinoma
Official title: A Multicenter, Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-Line Treatment of Subjects With Unresectable Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatocellular Carcinoma (HCC)
Keywords: Hepatocellular Carcinoma
Neoplasms
Cancer
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2013-01-04
Enrollment: 954
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: E7080-G000-304 is a multicenter, randomized, open-label, noninferiority Phase 3 study to compare the efficacy and safety of lenvatinib versus sorafenib as a first-line systemic treatment in participants with unresectable Hepatocellular Carcinoma (HCC).


Eligibility criteria: 1. Participants must have confirmed diagnosis of unresectable HCC with any of the following criteria:

   * Histologically or cytologically confirmed diagnosis of HCC.
   * Clinically confirmed diagnosis of HCC according to American Association for the Study of Liver Diseases (AASLD) criteria, including cirrhosis of any etiology or with chronic hepatitis B or C infection criteria
2. At least one measurable target lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) meeting the following criteria:

   • Hepatic lesion
   1. The lesion can be accurately measured in at least one dimension as \>=1.0 centimeter (cm) (viable tumor for typical; and longest diameter for atypical), and
   2. The lesion is suitable for repeat measurement.

      • Nonhepatic lesion
   3. Lymph node (LN) lesion that measures at least one dimension as \>=1.5 cm in the short axis, except for porta hepatis LN that measures \>=2.0 cm in the short axis.
   4. Non-nodal lesion that measures \>=1.0 cm in the longest diameter Lesions previously treated with radiotherapy or locoregional therapy must show radiographic evidence of disease progression to be deemed a target lesion.
3. Participants categorized to stage B (not applicable for transarterial chemoembolization \[TACE\]) or stage C based on Barcelona Clinic Liver Cancer (BCLC) staging system.
4. Adequate bone marrow function, defined as:

   * Absolute neutrophil count (ANC) \>=1.5 X 10\^9 per liter (/L)
   * Hemoglobin (Hb) \>=8.5 gram per deciliter (g/dL)
   * Platelet count \>=75 X 10\^9/L.
5. Adequate liver function, defined as:

   * Albumin \>=2.8 g/dL
   * Bilirubin less than or equal to (\<=) 3.0 mg/dL
   * Aspartate aminotransferase (AST), alkaline phosphatase (ALP), and alanine aminotransferase (ALT) \<=5 X the upper limit of normal (ULN).
6. Adequate blood coagulation function, defined as international normalized ratio (INR) \<=2.3.
7. Adequate renal function defined as creatinine clearance greater than (\>) 40 milliliter per minute (mL/min) calculated per the Cockcroft and Gault formula.
8. Adequate pancreatic function, defined as amylase and lipase \<=1.5 X ULN.
9. Adequately controlled blood pressure (BP) with up to 3 antihypertensive agents, defined as BP \<=150/90 millimeters of mercury (mmHg) at Screening and no change in antihypertensive therapy within 1 week prior to the Cycle1/Day1.
10. Child-Pugh score A.
11. Eastern Cooperative Oncology Group (ECOG)- performance status (PS) 0 or 1.
12. Males or females aged at least 18 years (or any age \>18 years as determined by country legislation) at the time of informed consent.
13. Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta-human chorionic gonadotropin \[B-hCG\] test with a minimum sensitivity of 25 International Units Per Liter (IU/L) or equivalent units of BhCG).

    A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
14. All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy or bilateral oophorectomy, all with surgery at least 1 month before dosing).
15. Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double barrier method \[such as condom plus diaphragm with spermicide\], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 30 days after study drug discontinuation. If currently abstinent, the participant must agree to use a double barrier method as described above if she becomes sexually active during the study period or for 30 days after study drug discontinuation. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation.
16. Male participants must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation). No sperm donation is allowed during the study period and for 30 days after study drug discontinuation.
17. Provide written informed consent.
18. Willing and able to comply with all aspects of the protocol.

Exclusion Criteria

1. Imaging findings for HCC corresponding to any of the following:

   * HCC with \>=50 percent liver occupation
   * Clear invasion into the bile duct
   * Portal vein invasion at the main portal branch (Vp4).
2. Participants who have received any systemic chemotherapy, including anti-vascular endothelial growth factor (VEGF) therapy, or any systemic investigational anticancer agents, including lenvatinib, for advanced/unresectable HCC. Note: Participants who have received local hepatic injection chemotherapy are eligible.
3. Participants who have received any anticancer therapy (including surgery, percutaneous ethanol injection, radio frequency ablation, transarterial \[chemo\] embolization, hepatic intra-arterial chemotherapy, biological, immunotherapy, hormonal, or radiotherapy) or any blood enhancing treatment (including blood transfusion, blood products, or agents that stimulate blood cell production, eg, granulocyte colony-stimulating factor \[G-CSF\]) within 28 days prior to randomization.
4. Participants who have not recovered from toxicities as a result of prior anticancer therapy, except alopecia and infertility. Recovery is defined as \< Grade 2 severity per Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0).
5. Significant cardiovascular impairment: history of congestive heart failure \> New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment at Screening.
6. Prolongation of corrected QT interval (QTc) interval to \>480 millisecond (ms)
7. Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib in the opinion of the investigator.
8. Bleeding or thrombotic disorders or use of anticoagulants requiring therapeutic INR monitoring, eg, warfarin or similar agents. Treatment with low molecular weight heparin and factor X inhibitors which do not require INR monitoring is permitted. Antiplatelet agents are prohibited throughout the study.
9. Gastrointestinal bleeding event or active hemoptysis (bright red blood of at least 0.5 teaspoon) within 28 days prior to randomization.
10. Gastric or esophageal varices that require interventional treatment within 28 days prior to randomization. Prophylaxis with pharmacologic therapy (eg, nonselective beta-blocker) is permitted.
11. Active malignancy (except for HCC or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 36 months.
12. Participants whose only target lesion(s) is in bone will be excluded.
13. Meningeal carcinomatosis.
14. Any history of or current brain or subdural metastases.
15. Participants having \>1+ proteinuria on urine dipstick testing will undergo a 24-hour urine collection for quantitative assessment of proteinuria. Participants with a urine protein \>=1g/24 hours will be ineligible.
16. Surgical arterial-portal venous shunt or arterial-venous shunt.
17. Any medical or other condition that in the opinion of the investigator would preclude the participant's participation in a clinical study.
18. Known intolerance to lenvatinib or sorafenib (or any of the excipients).
19. Human immunodeficiency virus (HIV) positive or active infection requiring treatment (except for hepatitis virus).
20. Any history of drug or alcohol dependency or abuse within the prior 6 months.
21. Any participant who cannot be evaluated by either triphasic liver computed tomography (CT) or triphasic liver Magnetic resonance imaging (MRI) because of allergy or other contraindication to both CT and MRI contrast agents.
22. Major surgery within 3 weeks prior to randomization or scheduled for surgery during the study.
23. Participants has had a liver transplant.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From date of randomization until date of death from any cause (approximately up to 3.8 years)
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (approximately up to 3.8 years)
measure: Time to Progression (TTP)
timeFrame: The time from the date of randomization to the date of first documentation of disease progression (approximately up to 3.8 years)
measure: Objective Response Rate (ORR)
timeFrame: From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (approximately up to 3.8 years)
measure: Time to Clinically Meaningful Worsening of Health Related Quality of Life (HRQoL) Assessed Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: Baseline up to Off-Treatment Visit (approximately up to 3.8 years)
measure: Time to Clinically Meaningful Worsening of HRQoL Assessed Using - EORTC QLQ- Hepatocellular Carcinoma Domain (HCC 18)
timeFrame: Baseline up to Off-Treatment Visit (approximately up to 3.8 years)
measure: Time to Clinically Meaningful Worsening of HRQoL Assessed Using EuroQol Five Dimension Health Questionnaire (EQ-5D-3L)
timeFrame: Baseline up to Off-Treatment Visit (approximately up to 3.8 years)
measure: Area Under the Plasma Drug Concentration-time Curve (AUC) for Lenvatinib
timeFrame: Cycle 1 Day 1, Cycle 2 Day 1: pre-dose, 0.5-4 and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 2-12 hours post-dose (cycle length= 28 days)
Other outcomes:
measure: Disease Control Rate (DCR)
timeFrame: From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (approximately up to 3.8 years)
measure: Clinical Benefit Rate (CBR)
timeFrame: From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (approximately up to 3.8 years)
measure: Percent Change From Baseline in Serum Biomarker
timeFrame: Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1, Cycle 8 Day 1, Cycle 9 Day 1 and at the Off-Treatment Visit (approximately up to 3.8 years)
Locations:
city: Los Angeles
country: United States
facility: Facility # 1
state: California
city: Sacramento
country: United States
facility: Facility # 1
state: California
city: San Francisco
country: United States
facility: Facility # 1
state: California
city: Washington
country: United States
facility: Facility # 1
state: District of Columbia
city: Tampa
country: United States
facility: Facility # 1
state: Florida
city: Duluth
country: United States
facility: Facility # 1
state: Georgia
city: Lawrenceville
country: United States
facility: Facility # 1
state: Georgia
city: Baltimore
country: United States
facility: Facility # 1
state: Maryland
city: Detroit
country: United States
facility: Facility # 1
state: Michigan
city: Kansas City
country: United States
facility: Facility # 1
state: Missouri
city: Saint Louis
country: United States
facility: Facility # 1
state: Missouri
city: East Orange
country: United States
facility: Facility # 1
state: New Jersey
city: Brooklyn
country: United States
facility: Facility # 1
state: New York
city: Lake Success
country: United States
facility: Facility # 1
state: New York
city: New York
country: United States
facility: Facility # 1
state: New York
city: Charlotte
country: United States
facility: Facility # 1
state: North Carolina
city: Durham
country: United States
facility: Facility # 1
state: North Carolina
city: Portland
country: United States
facility: Facility # 1
state: Oregon
city: Austin
country: United States
facility: Facility # 1
state: Texas
city: Lubbock
country: United States
facility: Facility # 1
state: Texas
city: Seattle
country: United States
facility: Facility # 1
state: Washington
city: Camperdown
country: Australia
facility: Facility # 1
state: New South Wales
city: Wentworthville
country: Australia
facility: Facility # 1
state: New South Wales
city: Woolloongabba
country: Australia
facility: Facility # 1
state: Queensland
city: Fitzroy
country: Australia
facility: Facility # 1
state: Victoria
city: Melbourne
country: Australia
facility: Facility # 1
state: Victoria
city: Melbourne
country: Australia
facility: Facility # 2
state: Victoria
city: Nedlands
country: Australia
facility: Facility # 1
state: Western Australia
city: Bruxelles
country: Belgium
facility: Facility # 1
city: Edegem
country: Belgium
facility: Facility # 1
city: Liege
country: Belgium
facility: Facility # 1
city: Ottawa
country: Canada
facility: Facility # 1
state: Ontario
city: Hefei
country: China
facility: Facility # 1
state: Anhui
city: Beijing
country: China
facility: Facility # 1
state: Beijing
city: Beijing
country: China
facility: Facility # 2
state: Beijing
city: Beijing
country: China
facility: Facility # 3
state: Beijing
city: Chongqing
country: China
facility: Facility # 1
state: Chongqing
city: Fuzhou
country: China
facility: Facility # 1
state: Fujian
city: Fuzhou
country: China
facility: Facility # 2
state: Fujian
city: Guangzhou
country: China
facility: Facility # 1
state: Guangdong
city: Harbin
country: China
facility: Facility # 1
state: Heilongjiang
city: Changsha
country: China
facility: Facility # 1
state: Hunan
city: Nanjing
country: China
facility: Facility # 1
state: Jiangsu
city: Suzhou
country: China
facility: Facility # 1
state: Jiangsu
city: Changchun
country: China
facility: Facility # 1
state: Jilin
city: Dalian
country: China
facility: Facility # 1
state: Liaoning
city: Jinan
country: China
facility: Facility # 1
state: Shandong
city: Shanghai
country: China
facility: Facility # 1
state: Shanghai
city: Shanghai
country: China
facility: Facility # 3
state: Shanghai
city: Xi'an
country: China
facility: Facility # 1
state: Shanxi
city: Xi'an
country: China
facility: Facility # 2
state: Shanxi
city: Hangzhou
country: China
facility: Facility # 1
state: Zhejiang
city: Tianjin
country: China
facility: Facility # 1
state: Zhejiang
city: Nice Cedex 3
country: France
facility: Facility # 1
state: Alpes Maritimes
city: Pessac Cedex
country: France
facility: Facility # 1
state: Gironde
city: Pessac
country: France
facility: Facility # 1
state: Gironde
city: Toulouse
country: France
facility: Facility # 1
state: Haute Garonne
city: Montpellier cedex 5
country: France
facility: Facility # 1
state: Herault
city: Rennes cedex
country: France
facility: Facility # 1
state: Ille Et Vilaine
city: Vandoeuvre les Nancy
country: France
facility: Facility # 1
state: Meurthe Et Moselle
city: Amiens cedex 1
country: France
facility: Facility # 1
state: Somme
city: Creteil Cedex
country: France
facility: Facility # 1
state: Val De Marne
city: Bordeaux
country: France
facility: Facility # 1
city: Lille cedex
country: France
facility: Facility # 1
city: Lyon
country: France
facility: Facility # 1
city: Nord
country: France
facility: Facility # 1
city: Paris cedex 12
country: France
facility: Facility # 1
city: Paris
country: France
facility: Facility # 1
city: Rhone
country: France
facility: Facility # 1
city: Heidelberg
country: Germany
facility: Facility # 1
state: Baden Wuerttemberg
city: Tuebingen
country: Germany
facility: Facility # 1
state: Baden Wuerttemberg
city: Marburg
country: Germany
facility: Facility # 1
state: Hessen
city: Hannover
country: Germany
facility: Facility # 1
state: Niedersachsen
city: Essen
country: Germany
facility: Facility # 1
state: Nordrhein Westfalen
city: Koeln
country: Germany
facility: Facility # 1
state: Nordrhein Westfalen
city: Mainz
country: Germany
facility: Facility # 1
state: Rheinland Pfalz
city: Hong Kong
country: Hong Kong
facility: Facility # 1
city: Hong Kong
country: Hong Kong
facility: Facility # 2
city: Hong Kong
country: Hong Kong
facility: Facility # 3
city: Kowloon
country: Hong Kong
facility: Facility # 1
city: Petach Tikva
country: Israel
facility: Facility # 1
city: Petah Tiqwa
country: Israel
facility: Facility # 1
city: Torrette
country: Italy
facility: Facility # 1
state: Ancona
city: Bari
country: Italy
facility: Facility # 1
city: Benevento
country: Italy
facility: Facility # 1
city: Bologna
country: Italy
facility: Facility # 1
city: Napoli
country: Italy
facility: Facility # 1
city: Napoli
country: Italy
facility: Facility # 2
city: Palermo
country: Italy
facility: Facility # 1
city: Roma
country: Italy
facility: Facility # 1
city: Nagoya
country: Japan
facility: Facility # 1
state: Aichi
city: Kashiwa
country: Japan
facility: Facility # 1
state: Chiba
city: Matsuyama
country: Japan
facility: Facility # 1
state: Ehime
city: Kurume
country: Japan
facility: Facility # 1
state: Fukuoka
city: Sapporo
country: Japan
facility: Facility # 1
state: Hokkaido
city: Sapporo
country: Japan
facility: Facility # 2
state: Hokkaido
city: Nishinomiya
country: Japan
facility: Facility # 1
state: Hyogo
city: Kanazawa
country: Japan
facility: Facility # 1
state: Ishikawa
city: Kawasaki
country: Japan
facility: Facility # 1
state: Kanagawa
city: Yokohama
country: Japan
facility: Facility # 1
state: Kanagawa
city: Tsu
country: Japan
facility: Facility # 1
state: Mie
city: Omura
country: Japan
facility: Facility # 1
state: Nagasaki
city: Osaka-Sayama
country: Japan
facility: Facility # 1
state: Osaka
city: Bunkyo-Ku
country: Japan
facility: Facility # 1
state: Tokyo
city: Chuo-ku
country: Japan
facility: Facility # 1
state: Tokyo
city: Koto-ku
country: Japan
facility: Facility # 1
state: Tokyo
city: Minato-ku
country: Japan
facility: Facility # 1
state: Tokyo
city: Musashino
country: Japan
facility: Facility # 1
state: Tokyo
city: Shimonoseki
country: Japan
facility: Facility # 1
state: Yamaguchi
city: Fukuoka
country: Japan
facility: Facility # 1
city: Hiroshima
country: Japan
facility: Facility # 1
city: Okayama
country: Japan
facility: Facility # 1
city: Osaka
country: Japan
facility: Facility # 2
city: Saga
country: Japan
facility: Facility # 1
city: Saga
country: Japan
facility: Facility # 2
city: Goyang-si
country: Korea, Republic of
facility: Facility # 1
state: Gyeonggi-do
city: Seongnam-Si
country: Korea, Republic of
facility: Facility # 1
state: Gyeonggi-do
city: Seongnam-Si
country: Korea, Republic of
facility: Facility # 2
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Facility # 1
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Facility # 1
state: Gyeongsangbuk-do
city: Hwasun
country: Korea, Republic of
facility: Facility # 1
state: Jeollanam-do
city: Busan
country: Korea, Republic of
facility: Facility # 1
city: Busan
country: Korea, Republic of
facility: Facility # 2
city: Busan
country: Korea, Republic of
facility: Facility # 3
city: Incheon
country: Korea, Republic of
facility: Facility # 1
city: Seoul
country: Korea, Republic of
facility: Facility # 1
city: Seoul
country: Korea, Republic of
facility: Facility # 2
city: Seoul
country: Korea, Republic of
facility: Facility # 3
city: Seoul
country: Korea, Republic of
facility: Facility # 4
city: Seoul
country: Korea, Republic of
facility: Facility # 5
city: Seoul
country: Korea, Republic of
facility: Facility # 6
city: Seoul
country: Korea, Republic of
facility: Facility # 7
city: Seoul
country: Korea, Republic of
facility: Facility # 8
city: Kuantan
country: Malaysia
facility: Facility # 1
state: Pahang
city: Penang
country: Malaysia
facility: Facility # 1
state: Pulau Pinang
city: Miri
country: Malaysia
facility: Facility # 1
state: Sarawak
city: Batu Caves
country: Malaysia
facility: Facility # 1
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: Facility # 1
city: Cebu City
country: Philippines
facility: Facility # 1
city: Cebu City
country: Philippines
facility: Facility # 2
city: Davao City
country: Philippines
facility: Facility # 1
city: Quezon City
country: Philippines
facility: Facility # 1
city: Quezon City
country: Philippines
facility: Facility # 2
city: Gdansk
country: Poland
facility: Facility # 1
city: Warszawa
country: Poland
facility: Facility # 1
city: Wroclaw
country: Poland
facility: Facility # 1
city: Arkhangelsk
country: Russian Federation
facility: Facility # 1
city: Moscow
country: Russian Federation
facility: Facility # 1
city: Moscow
country: Russian Federation
facility: Facility # 2
city: Saint Petersburg
country: Russian Federation
facility: Facility # 3
city: Saint Petersburg
country: Russian Federation
facility: Facility # 4
city: Ufa
country: Russian Federation
facility: Facility # 1
city: Singapore
country: Singapore
facility: Facility # 1
city: Singapore
country: Singapore
facility: Facility # 2
city: Singapore
country: Singapore
facility: Facility # 3
city: Singapore
country: Singapore
facility: Facility # 4
city: L'Hospitalet de Llobregat
country: Spain
facility: Facility # 1
state: Barcelona
city: Santander
country: Spain
facility: Facility # 1
state: Cantabria
city: Badajoz
country: Spain
facility: Facility # 1
city: Girona
country: Spain
facility: Facility # 1
city: Madrid
country: Spain
facility: Facility # 1
city: Madrid
country: Spain
facility: Facility # 2
city: Madrid
country: Spain
facility: Facility # 3
city: Madrid
country: Spain
facility: Facility # 4
city: Kaohsiung
country: Taiwan
facility: Facility # 1
city: Kaohsiung
country: Taiwan
facility: Facility # 2
city: Taichung
country: Taiwan
facility: Facility # 1
city: Taichung
country: Taiwan
facility: Facility # 2
city: Tainan
country: Taiwan
facility: Facility # 1
city: Tainan
country: Taiwan
facility: Facility # 2
city: Taipei
country: Taiwan
facility: Facility # 1
city: Taipei
country: Taiwan
facility: Facility # 2
city: Taipei
country: Taiwan
facility: Facility # 3
city: Taipei
country: Taiwan
facility: Facility # 4
city: Taipei
country: Taiwan
facility: Facility # 5
city: Taoyuan City
country: Taiwan
facility: Facility # 1
city: Bangkoknoi
country: Thailand
facility: Facility # 1
state: Bangkok
city: Pathum Wan
country: Thailand
facility: Facility # 1
state: Bangkok
city: Ratchathewi
country: Thailand
facility: Facility # 1
state: Bangkok
city: Muang
country: Thailand
facility: Facility # 1
state: Chiang Mai
city: Muang
country: Thailand
facility: Facility # 1
state: Chiang Rai
city: London
country: United Kingdom
facility: Facility # 2
state: Greater London
city: London
country: United Kingdom
facility: Facility # 1
state: Greater London
city: London
country: United Kingdom
facility: Facility # 3
state: Greater London
city: Manchester
country: United Kingdom
facility: Facility # 1
state: Greater Manchester
city: Liverpool
country: United Kingdom
facility: Facility # 1
state: Merseyside
city: Glasgow
country: United Kingdom
facility: Facility # 1
state: Strathclyde
city: Birmingham
country: United Kingdom
facility: Facility # 1
state: West Midlands
Study officials:
References:
citation: Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Cheng AL, Vogel A, Tovoli F, Ueshima K, Aikata H, Lopez CL, Pracht M, Meng Z, Daniele B, Park JW, Palmer D, Tamai T, Saito K, Dutcus CE, Lencioni R. Overall survival and objective response in advanced unresectable hepatocellular carcinoma: A subanalysis of the REFLECT study. J Hepatol. 2023 Jan;78(1):133-141. doi: 10.1016/j.jhep.2022.09.006. Epub 2022 Sep 20.
citation: Huynh J, Cho MT, Kim EJ, Ren M, Ramji Z, Vogel A. Lenvatinib in patients with unresectable hepatocellular carcinoma who progressed to Child-Pugh B liver function. Ther Adv Med Oncol. 2022 Aug 24;14:17588359221116608. doi: 10.1177/17588359221116608. eCollection 2022.
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