Clinical trial NCT03434379: A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
Official title: A Phase III, Open-Label, Randomized Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Hepatocellular
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2018-02-15
Enrollment: 558
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: This study will evaluate the efficacy and safety of atezolizumab in combination with bevacizumab compared with sorafenib in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have received no prior systemic treatment.

Detailed description: The participants will be randomized in a 2:1 ratio to one of the two treatment arms: Arm A (experimental arm): Atezolizumab +bevacizumab; Arm B (control arm): Sorafenib

Eligibility criteria: Inclusion Criteria:

* Locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC)
* No prior systemic therapy for HCC. Previous use of herbal therapies/traditional Chinese medicines with anti-cancer activity included in the label is allowed, provided that these medications are discontinued prior to randomization.
* At least one measurable untreated lesion
* ECOG Performance Status of 0 or 1
* Adequate hematologic and end-organ function
* For women of childbearing potential: agreement to remain abstinent
* For men: agreement to remain abstinent
* Child-Pugh class A

Exclusion Criteria:

* History of leptomeningeal disease
* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
* Known active tuberculosis
* History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after the last dose of atezolizumab, 6 months after the last dose of bevacizumab, or 1 month after the last dose of sorafenib
* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
* Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high-risk for bleeding
* A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment.
* Moderate or severe ascites
* History of hepatic encephalopathy
* Co-infection of HBV and HCV
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* Uncontrolled tumor-related pain
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
* Uncontrolled or symptomatic hypercalcemia
* Treatment with systemic immunostimulatory agents
* Inadequately controlled arterial hypertension
* Prior history of hypertensive crisis or hypertensive encephalopathy
* Evidence of bleeding diathesis or significant coagulopathy
* History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction including sub-occlusive disease related to the underlying disease or requirement for routine parenteral hydration
* Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
* Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses
* Local therapy to liver within 28 days prior to initiation of study treatment or non-recovery from side effects of any such procedure
* Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID)

Primary outcomes:
measure: Overall Survival (OS) in the Global Population
timeFrame: From randomization to death from any cause up to the clinical cut off date (CCOD) of 29Aug2019 (up to approximately 18 months) and 31Aug2020 (up to approximately 30 months)
measure: Progression Free Survival by Independent Review Facility-Assessment (PFS-IRF) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in the Global Population
timeFrame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: Overall Survival (OS) in the China Population
timeFrame: From randomization to death from any cause up to the clinical cut off date (CCOD) of 29Aug2019 (up to approximately 18 months) and 31Aug2020 (up to approximately 30 months)
measure: PFS-IRF Per RECIST v1.1 in the China Population
timeFrame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
Secondary outcomes:
measure: Objective Response Rate by IRF-Assessment (ORR-IRF) Per RECIST v1.1 in the Global Population
timeFrame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: Objective Response Rate by IRF-Assessment (ORR-IRF) Per Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST) in the Global Population
timeFrame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: ORR by Investigator-Assessment (ORR-INV) Per RECIST v1.1 in the Global Population
timeFrame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the Global Population
timeFrame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the Global Population
timeFrame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: Duration of Response by Investigator Assessment (DOR-INV) Per RECIST v1.1 in the Global Population
timeFrame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: PFS-IRF Per HCC mRECIST in the Global Population
timeFrame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: PFS by Investigator Assessment (PFS-INV) Per RECIST v1.1 in the Global Population
timeFrame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: Time to Progression (TTP) by IRF Assessment (TTP-IRF) Per RECIST v1.1 in the Global Population
timeFrame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: TTP-IRF Per HCC mRECIST in the Global Population
timeFrame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: TTP by Investigator Assessment (TTP-INV) Per RECIST v1.1 in the Global Population
timeFrame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: Overall Survival by Baseline AFP in the Global Population
timeFrame: From randomization to death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: PFS-IRF Per RECIST v1.1 by Baseline AFP in the Global Population
timeFrame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: PFS-INV Per RECIST v1.1 by Baseline AFP in the Global Population
timeFrame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: Time to Deterioration (TTD) in the Global Population
timeFrame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: Number of Participants With Adverse Events (AEs) in the Global Population
timeFrame: Up to end of study (up to approximately 56 months)
measure: Maximum Serum Concentration (Cmax) of Atezolizumab at Cycle 1 in the Global Population
timeFrame: Post-dose on Day 1 of Cycle 1 (cycle length = 21 days)
measure: Trough Serum Concentration (Cmin) of Atezolizumab in the Global Population
timeFrame: Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (cycle length = 21 days)
measure: Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab in the Global Population
timeFrame: Baseline and post-baseline on Day 1 (pre-dose) of Cycles 2, 3, 4, 8, 12, 16 (cycle length = 21 days) and treatment discontinuation visit (up to approximately 30 months)
measure: Objective Response Rate by IRF-Assessment (ORR-IRF) Per RECIST v1.1 in the China Population
timeFrame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: Objective Response Rate by IRF-Assessment (ORR-IRF) Per Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST) in the China Population
timeFrame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: ORR by Investigator-Assessment (ORR-INV) Per RECIST v1.1 in the China Population
timeFrame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the China Population
timeFrame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the China Population
timeFrame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: Duration of Response by Investigator Assessment (DOR-INV) Per RECIST v1.1 in the China Population
timeFrame: Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: PFS-IRF Per HCC mRECIST in the China Population
timeFrame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: PFS by Investigator Assessment (PFS-INV) Per RECIST v1.1 in the China Population
timeFrame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: Time to Progression (TTP) by IRF Assessment (TTP-IRF) Per RECIST v1.1 in the China Population
timeFrame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: TTP-IRF Per HCC mRECIST in the China Population
timeFrame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: TTP by Investigator Assessment (TTP-INV) Per RECIST v1.1 in the China Population
timeFrame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: Time to Deterioration (TTD) in the China Population
timeFrame: Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
measure: Number of Participants With Adverse Events (AEs) in the China Population
timeFrame: Up to end of study (up to approximately 56 months)
measure: Maximum Serum Concentration (Cmax) of Atezolizumab in the China Population
timeFrame: Post-dose on Day 1 of Cycle 1 (cycle length = 21 days)
measure: Trough Serum Concentration (Cmin) of Atezolizumab in the China Population
timeFrame: Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (cycle length = 21 days)
measure: Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab in the China Population
timeFrame: Baseline and post-baseline on Day 1 (pre-dose) of Cycles 2, 3, 4, 8, 12, 16 (cycle length = 21 days) and treatment discontinuation visit (up to approximately 18 months)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Josephs Hospital and Medical Center
state: Arizona
city: Duarte
country: United States
facility: City of Hope
state: California
city: La Jolla
country: United States
facility: Uni of California - San Diego; Cancer Center & Dept of Medicine
state: California
city: Novato
country: United States
facility: Kaiser Permanente Northern California
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Sacramento Medical Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente - San Francisco Medical Center
state: California
city: Santa Monica
country: United States
facility: University of California Los Angeles
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente - Walnut Creek
state: California
city: Greeley
country: United States
facility: Banner MD Anderson Cancer Center
state: Colorado
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Louis
country: United States
facility: Washington University; Wash Uni. Sch. Of Med
state: Missouri
city: Albuquerque
country: United States
facility: University of New Mexico Comprehensive Cancer Center
state: New Mexico
city: New York
country: United States
facility: Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Houston
country: United States
facility: M.D Anderson Cancer Center; Uni of Texas At Houston
state: Texas
city: Seattle
country: United States
facility: Swedish Cancer Inst.
state: Washington
city: Bankstown
country: Australia
facility: Bankstown-Lidcombe Hospital
state: New South Wales
city: Kogarah
country: Australia
facility: St George Hospital
state: New South Wales
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: St Albans
country: Australia
facility: Sunshine Hospital
state: Victoria
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
city: Montreal
country: Canada
facility: Centre hospitalier de l'Universite de Montreal (CHUM)
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre - Glen Site
state: Quebec
city: Beijing City
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Beijing Friendship Hospital
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Changchun
country: China
facility: the First Hospital of Jilin University
city: Changchun
country: China
facility: Jilin Cancer Hospital
city: Changsha CITY
country: China
facility: Hunan Cancer Hospital
city: Foshan
country: China
facility: The First People's Hospital of Foshan; Local Ethic Committee
city: Fuzhou
country: China
facility: The 900th Hospital of PLA joint service support force
city: Guangzhou City
country: China
facility: Sun Yet-sen University Cancer Center
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
city: Hangzhou City
country: China
facility: Sir Run Run Shaw Hospital
city: Hangzhou City
country: China
facility: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Hefei City
country: China
facility: Anhui Province Cancer Hospital
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
city: Jinan
country: China
facility: General Hospital of Jinan Military Command of PLA
city: Nanjing City
country: China
facility: The 81st Hospital of P.L.A.
city: Shanghai City
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Wuhan
country: China
facility: Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc; Onkologicka klinika
city: Lille
country: France
facility: Hopital Claude Huriez;Gastro Enterologie
city: Lyon
country: France
facility: Hopital De La Croix Rousse; Hepatologie Gastro Enterologie
city: Marseille
country: France
facility: Hopital Timone Adultes; Gastro Enterologie
city: Montpellier
country: France
facility: Hopital Saint-Eloi; Hepatologie-Gastro-Enterologie
city: Nantes
country: France
facility: Hopital Hotel Dieu Et Hme; Hepatologie Gastro Enterologie
city: Nice Cedex
country: France
facility: CHU Nice - Hôpital de l'Archet 2; service Hepato gastro enterologie
city: Rouen
country: France
facility: Hopital Charles Nicolle; Gastroenterologie
city: Strasbourg
country: France
facility: Hopital Hautepierre; Gastro Enterologie
city: Vandoeuvre-les-nancy
country: France
facility: Hôpital d'Adultes; Service hépato-gastro-entérologie
city: Villejuif
country: France
facility: Institut Gustave Roussy; Gastro-Enterologie
city: Berlin
country: Germany
facility: Campus Virchow-Klinikum Charité Centrum 13; Medizinische Klinik; Abt.Hepatologie u.Gastroenterologie
city: Frankfurt
country: Germany
facility: Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf; I. Medizinische Klinik - Gastroenterologie
city: Hannover
country: Germany
facility: Med. Hochschule Hannover; Gastroenterologie
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig Medizinische Klinik II Gastroenterolog. u. Hepatolog.
city: Mainz
country: Germany
facility: Uniklinik Mainz; I. Medizinische Klinik
city: Regensburg
country: Germany
facility: Klinikum der Uni Regensburg; Klinik f.Innere Medizin I Abt. Hämatologie und Internistische Onkologie
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital; Dept. Of Haematology & Oncology
city: Shatin
country: Hong Kong
facility: Prince of Wales Hosp; Dept. Of Clinical Onc
city: Benevento
country: Italy
facility: Az. Osp. Rummo; Oncologia Medica
state: Campania
city: Meldola
country: Italy
facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
state: Emilia-Romagna
city: Orbassano
country: Italy
facility: Az. Osp. S. Luigi Gonzaga; Divisione Di Oncologia Medica
state: Piemonte
city: Cagliari
country: Italy
facility: A.O.U. Cagliari-P.O. Monserrato;U.O. Oncologia
state: Sardegna
city: Pisa
country: Italy
facility: Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria ? Polo Oncologico
state: Toscana
city: Padova
country: Italy
facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima
state: Veneto
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Chiba
country: Japan
facility: National Cancer Center Hospital East
city: Fukuoka
country: Japan
facility: Kurume University Hospital
city: Hokkaido
country: Japan
facility: Sapporo Kosei Genaral Hospital
city: Hokkaido
country: Japan
facility: Hokkaido University Hospital
city: Ishikawa
country: Japan
facility: Kanazawa University Hospital
city: Kanagawa
country: Japan
facility: Kitasato University Hospital
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Osaka
country: Japan
facility: Kindai University Hospital
city: Saga
country: Japan
facility: Saga-ken Medical Centre Koseikan
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
city: Tokyo
country: Japan
facility: Japanese Red Cross Musashino Hospital
city: Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hosiptal
city: Gdansk
country: Poland
facility: Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii
city: Myslowice
country: Poland
facility: ID Clinic
city: Olsztyn
country: Poland
facility: SP ZOZ MSWiA z WARMINSKO-MAZURSKIM CENTRUM ONKOLOGII; CLINICAL ONCOLOGY, CLINICAL IMMUNOLOGY
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy
city: Wroc?aw
country: Poland
facility: Dolno?l?skie Centrum Onkologii; Oddzia? Onkologii Klinicznej i Chemioterapii
city: Moscow
country: Russian Federation
facility: FSBI "National Medical Research Center of Oncology N.N. Blokhin?; Clinical Biotechnologies
state: Moskovskaja Oblast
city: Saint Petersburg
country: Russian Federation
facility: GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
state: Sankt Petersburg
city: Singapore
country: Singapore
facility: National Cancer Centre
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital; Oncology
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron; Oncology
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz; Servicio de Oncologia
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campal; Servicio de Oncología
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet; Servicio de Oncologia Medica
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital; Oncology
city: Tainan
country: Taiwan
facility: Chi-Mei Medical Centre; Hematology & Oncology
city: Taipei
country: Taiwan
facility: Veterans General Hospital; Cancer Center
city: Taipei
country: Taiwan
facility: National Taiwan Uni Hospital; Dept of Oncology
city: Taoyuan County
country: Taiwan
facility: Chang Gung Memorial Hospital-Linkou; Dept of Oncology
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: London
country: United Kingdom
facility: Royal Free Hospital; Dept of Oncology
city: London
country: United Kingdom
facility: King'S College Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital Nhs Trust; Medical Oncology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Kaseb AO, Guan Y, Gok Yavuz B, Abbas AR, Lu S, Hasanov E, Toh HC, Verret W, Wang Y. Serum IGF-1 Scores and Clinical Outcomes in the Phase III IMbrave150 Study of Atezolizumab Plus Bevacizumab versus Sorafenib in Patients with Unresectable Hepatocellular Carcinoma. J Hepatocell Carcinoma. 2022 Oct 11;9:1065-1079. doi: 10.2147/JHC.S369951. eCollection 2022.
citation: Li Y, Liang X, Li H, Chen X. Atezolizumab plus bevacizumab versus nivolumab as first-line treatment for advanced or unresectable hepatocellular carcinoma: A cost-effectiveness analysis. Cancer. 2022 Nov 15;128(22):3995-4003. doi: 10.1002/cncr.34457. Epub 2022 Sep 16.
citation: Cheng AL, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Lim HY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Ma N, Nicholas A, Wang Y, Li L, Zhu AX, Finn RS. Updated efficacy and safety data from IMbrave150: Atezolizumab plus bevacizumab vs. sorafenib for unresectable hepatocellular carcinoma. J Hepatol. 2022 Apr;76(4):862-873. doi: 10.1016/j.jhep.2021.11.030. Epub 2021 Dec 11.
citation: Salem R, Li D, Sommer N, Hernandez S, Verret W, Ding B, Lencioni R. Characterization of response to atezolizumab + bevacizumab versus sorafenib for hepatocellular carcinoma: Results from the IMbrave150 trial. Cancer Med. 2021 Aug;10(16):5437-5447. doi: 10.1002/cam4.4090. Epub 2021 Jun 29.
citation: Galle PR, Finn RS, Qin S, Ikeda M, Zhu AX, Kim TY, Kudo M, Breder V, Merle P, Kaseb A, Li D, Mulla S, Verret W, Xu DZ, Hernandez S, Ding B, Liu J, Huang C, Lim HY, Cheng AL, Ducreux M. Patient-reported outcomes with atezolizumab plus bevacizumab versus sorafenib in patients with unresectable hepatocellular carcinoma (IMbrave150): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Jul;22(7):991-1001. doi: 10.1016/S1470-2045(21)00151-0. Epub 2021 May 27.
citation: Wen F, Zheng H, Zhang P, Liao W, Zhou K, Li Q. Atezolizumab and bevacizumab combination compared with sorafenib as the first-line systemic treatment for patients with unresectable hepatocellular carcinoma: A cost-effectiveness analysis in China and the United states. Liver Int. 2021 May;41(5):1097-1104. doi: 10.1111/liv.14795. Epub 2021 Feb 8.
citation: Finn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Xu DZ, Hernandez S, Liu J, Huang C, Mulla S, Wang Y, Lim HY, Zhu AX, Cheng AL; IMbrave150 Investigators. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020 May 14;382(20):1894-1905. doi: 10.1056/NEJMoa1915745.