A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

557

Participants

Timeline

Start Date

April 26, 2021

Primary Completion Date

September 26, 2025

Study Completion Date

October 17, 2025

Conditions
Unresectable Hepatocellular Carcinoma
Interventions
DRUG

Atezolizumab

Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

DRUG

Lenvatinib

Lenvatinib will be administered once daily by mouth each day of every 21-day study treatment cycle. Participants with a baseline body weight of \< 60 kg will receive a daily dose of 8 mg. Participants with a baseline body weight of ≥ 60 kg will receive a daily dose of 12 mg.

DRUG

Sorafenib

Sorafenib will be administered at a dose of 800 mg per day, i.e. two tablets of 200 mg swallowed by mouth twice daily (equivalent to a total daily dose of 800 mg) each day of every 21-day study treatment cycle.

Trial Locations (123)

710

Chi-Mei Medical Centre, Tainan City

1000

University Medical Center Ljubljana, Ljubljana

1070

Hospital Erasme, Brussels

1100

Klinik Favoriten, Vienna

1200

Cliniques Universitaires St-Luc, Brussels

1229

Makati Medical Center, Makati City

1600

The Medical City, Pasig

2930

AZ KLINA, Brasschaat

3000

UZ Leuven, Leuven

3010

Inselspital Bern Medizin Gastroenterologie, Bern

3100

Universitätsklinikum St. Pölten, Sankt Pölten

4004

Complex Oncological Center - Plovdiv, EOOD, Plovdiv

4500

Multiprofile Hospital for Active Treatment Uni Hospital, Panagyurishte

5020

Uniklinikum Salzburg, LKH, Salzburg

6000

Cebu Doctors' University Hospital, Cebu City

6020

Medizinische Universität Innsbruck, Innsbruck

8091

Universitätsspital Zürich Medizin Gastroenterologie, Zurich

8800

AZ Delta (Campus Rumbeke), Roeselare

10000

Clinical Hospital Centre Zagreb, Zagreb

10048

National Taiwan University Hospital, Zhongzheng Dist.

10103

Clinica CIMCA, San José

10108

ICIMED Instituto de Investigación en Ciencias Médicas, San José

10128

Azienda Ospedaliera Ordine Mauriziano di Torino, Turin

10330

Chulalongkorn Hospital, Bangkok

10408

National Cancer Center, Goyang-si

10700

Faculty of Med. Siriraj Hosp., Bangkok

11391

AirForce Specialized Hospital, Cairo

12345

Anhui Province Cancer Hospital, Hefei

13385

APHM, Marseille

13419

North Estonia Medical Centre, Oncology and hematology Clinic, Tallinn

13496

CHA Bundang Medical Center, Gyeonggi-do

14004

Hospital Universitario Reina Sofia, Córdoba

14564

Agioi Anargiroi Hospital of Kifissia, Nea Kifissia

15706

Complejo Hospitalario Universitario de Santiago (CHUS), Santiago de Compostela

16059

Uludag Uni Hospital, Bursa

20122

Fondazione IRCCS Ospedale Maggiore Policlinico, Milan

28007

Hospital General Universitario Gregorio Marañon, Madrid

28027

Clinica Universidad de Navarra Madrid, Madrid

28050

START Madrid. Centro Integral Oncologico Clara Campal, Madrid

30625

Med. Hochschule Hannover, Hanover

31008

Clinica Universitaria de Navarra, Pamplona/iruña

31059

CHU de Toulouse - Hôpital Rangueil, Toulouse

33520

TAYS Radius rakennus, Tampere

33604

CHU Bordeaux, Pessac

34147

Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji, Bakirkoy / Istanbul

34214

Medipol Mega Üniversite Hastanesi Göztepe, Ba?c?lar

34295

CH Saint Eloi, Montpellier

35042

Centre Eugene Marquis;Service d'oncologie, Rennes

35100

Ege Uni Medical Faculty Hospital, Izmir

35128

IRCCS Istituto Oncologico Veneto (IOV), Padua

38043

CHU Grenoble Sud, Grenoble

40138

A.O. S. Orsola Malpighi, Bologna

44093

CHU de Nantes - Hotel Dieu, Nantes

46026

Hospital Universitario la Fe, Valencia

50009

Hospital Universitario Miguel Servet, Zaragoza

50139

Azienda Ospedaliero-Universitaria Careggi, Florence

50406

Tartu University Hospital, Tartu

54511

Hopitaux de Brabois - Gastro-Entereologie, Vandœuvre-lès-Nancy

55131

Uniklinik Mainz, Mainz

56100

Azlenda Ospendaliero-Universitaria Pisana, Pisa

59037

CHRU de Lille - Hopital Claude Huriez, Lille

59100

Uni Malaya Medical Center, Kuala Lumpur

60590

Klinik Johann Wolfgang von Goethe Uni, Frankfurt

62250

Institute Kanser Negara (IKN), Putrajaya

72076

Universität Tübingen, Tübingen

75571

APHP - Hopital Saint Antoine, Paris

80100

Fondazione Pascale, Napoli

80131

Azienda Osp Uni Seconda Università Degli Studi Di Napoli, Napoli

80147

Ospedale del Mare, Napoli

89081

Universitätsklinikum Ulm, Ulm

90127

A.O.U. Policlinico Paolo Giaccone, Palermo

94804

Hopital Paul Brousse, Villejuif

110004

Shengjing Hospital of China Medical University, Shenyang

115478

"FSBI National Medical Research Center of Oncology N.N. Blokhin?", Moscow

119991

I.M.Sechenov First Moscow State Medical University (1st MSMU), Moskva

125134

Moscow City Oncology Hospital #62, Moscow

200032

Zhongshan Hospital Fudan University, Shanghai

200127

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai

210029

Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University), Nanjing

300060

Tianjin Cancer Hospital, Tianjin

350001

Fujian Provincial Hospital, Fuzhou

410013

Hunan Cancer Hospital, Changsha

510080

The First Affiliated Hospital, Sun Yat-sen University, Guangzhou

510515

Nanfang Hospital, Southern Medical University, Guangzhou

3109601

Rambam Health Care Campus, Haifa

4941492

Rabin Medical Center, Petah Tikva

6423900

Sourasky Medical Center, Tel Aviv

30110-160

Hospital Felicio Rocho, Belo Horizonte

90035-000

Hospital Moinhos de Vento, Porto Alegre

90610-000

Hospital Sao Lucas - PUCRS, Porto Alegre

88020-210

Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN, Florianópolis

22290-160

Clinicas Oncologicas Integradas - COI, Rio de Janeiro

01321-00

Beneficencia Portuguesa de Sao Paulo, São Paulo

T2N 4N2

Arthur J.E. Child Comprehensive Cancer Center-Calgary, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

L8V 5C2

Juravinski Cancer Centre, Hamilton

M5G 2M9

Princess Margaret Cancer Center, Toronto

115 27

Laiko General Hospital Athen, Athens

00152

Azienda Ospedaliera San Camillo Forlanini, Rome

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

470-1192

Fujita Health University Hospital, Aichi

277-8577

National Cancer Center Hospital East, Chiba

830-0011

Kurume University Hospital, Fukuoka

734-8551

Hiroshima University Hospital, Hiroshima

670-8540

Japanese Red Cross Society Himeji Hospital, Hyōgo

232-0024

Yokohama City University Medical Center, Kanagawa

565-0871

The University of Osaka Hospital, Osaka

589-8511

Kindai University Hospital, Osaka

329-0498

Jichi Medical University Hospital, Tochigi

180-8610

Japanese Red Cross Musashino Hospital, Tokyo

(0)6351

Samsung Medical Center, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

07198

Hospital Son Llatzer, Palma de Mallorca

06520

Memorial Ankara Hastanesi, Ankara

Unknown

Ac?badem Altunizade Hastanesi, Istanbul

06230

Hacettepe Uni Medical Faculty Hospital, Sihhiye/Ankara

L7 8YA

The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool

NW3 2QS

Royal Free Hospital, London

SE5 9RS

King College Hospital NHS Foundation Trust, London

W12 0HS

Hammersmith Hospital, London

M2O 4BX

Christie Hospital Nhs Trust, Manchester

NE7 7DN

Freeman Hospital, Newcastle upon Tyne

OX3 7LE

Churchill Hospital, Oxford

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT04770896 - A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab | Biotech Hunter | Biotech Hunter