Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone

PHASE3CompletedINTERVENTIONAL
Enrollment

459

Participants

Timeline

Start Date

October 31, 2015

Primary Completion Date

July 31, 2020

Study Completion Date

July 31, 2020

Conditions
Hepatocellular Carcinoma (HCC)
Interventions
BIOLOGICAL

Pexastimogene Devacirepvec (Pexa Vec)

Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells.

DRUG

Sorafenib

"Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05.~Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo.~Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease."

Trial Locations (142)

1142

Auckland City Hospital, Auckland

19104

Hospital of The University of Pennsylvania, Philadelphia

21202

Mercy Medical Center, Inc., Baltimore

32608

University of Florida Shands Hospital, Gainesville

35294

University of Alabama, Birmingham

37920

University of Tennessee Medical Center, Knoxville

40202

University of Louisville, Louisville

43210

Ohio State University, Columbus

55455

University of Minnesota, Minneapolis

59101

Billings Clinic, Billings

60637

University of Chicago, Chicago

63104

Saint Louis University, St Louis

63110

Washington University School of Medicine, St Louis

64131

Kansas City Research Institute, Kansas City

66205

University of Kansas Cancer Center, Kansas City

70112

Tulane University Health Sciences Center, New Orleans

75390

University of Texas Southwestern Medical Center, Dallas

85259

Mayo Clinic Arizona, Scottsdale

92868

UC Irvine Medical Center, Orange

94304

Stanford University School of Medicine, Palo Alto

98101

Benaroya Research Institute at Virginia Mason Hospital, Seattle

07960

Morristown Medical Center, Morristown

07503

St. Joseph's Hospital, Paterson

02903

Rhode Island Hospital, Providence

Unknown

Site No. 8409, Adelaide

Site No. 8412, Adelaide

Site No. 8403, Brisbane

Site No. 8401, Camperdown

Site No. 8407, Clayton

Site No. 8406, Concord

Site No. 8408, Fitzroy

Site No. 8405, Footscray

Site No. 8414, Heidelberg

Site No. 8411, Melbourne

Site No. 8402, Parkville

Site No. 8415, Perth

Site No. 8413, Sydney

Site 8829, Changchun

Site No. 8821, Changsha

Site 8811, Fuzhou

Site 8820, Fuzhou

Site No.8816, Guangdong

Site 8827, Guangzhou

Site No.8828, Guangzhou

Site 8832, Hangzhou

Site No. 8802, Harbin

Site 8805, Hefei

Site No. 8808, Hefei

Site No.8815, Hefei

Site No. 8801, Nanjing

Site 8833, Qingdao

Site 8806, Shanghai

Site 8822, Shanghai

Site 8831, Shanghai

Site No. 8823, Xi'an

Site No. 8825, Xi'an

Site No. 9013, Bondy

Site No. 9005, Bordeaux

Site No. 9003, Créteil

Site No. 9006, Lille

Site 9012, Montpellier

Site No. 9008, Nantes

Site No. 9010, Nice

Site No. 9007, Paris

Site No. 9014, Paris

Site No. 9011, Rennes

Site No. 9001, Strasbourg

Site No. 9002, Toulouse

Site No. 9009, Vandœuvre-lès-Nancy

Site No. 9111, Aachen

Site No. 9113, Bonn

Site No. 9109, Dresden

Site No. 9108, Frankfurt am Main

Site No. 9106, Hamburg

Site No 9105, Hannover

Site No. 9112, Heidelberg

Site No. 9101, Mainz

Site No. 9102, München

Site No. 9104, Tübingen

Site No. 9110, Ulm

Site No. 8601, Hong Kong

Site No. 9707, Afula

Site 9704, Haifa

Site No. 9702, Haifa

Site No. 9705, Jerusalem

Site No. 9703, Ramat Gan

Site No. 9706, Tel Aviv

Site No.9205, Modena

Site No. 9204, Napoli

Site No. 9201, Palermo

Site No. 9203, Parma

Site No. 8902, Christchurch

Site No. 9404, Coimbra

Site No. 9405, Coimbra

Site No. 9403, Lisbon

Site No. 9401, Porto

Site No. 9402, Porto

Site 8702, Singapore

Site 8703, Singapore

Site No. 8701, Singapore

Site No. 8208, Ansan

Site No. 8211, Bucheon-si

Site No. 8201, Busan

Site 8216, Daegu

Site No. 8207, Daegu

Site No. 8213, Daegu

Site No. 8220, Daegu

Site 8224, Goyang

Site No. 8221, Jinju

Site No. 8218, Pusan

Site No. 8222, Seongnam

Site No. 8219, Seongnam-si

Site No. 8202, Seoul

Site No. 8203, Seoul

Site No. 8205, Seoul

Site No. 8209, Seoul

Site No. 8212, Seoul

Site No. 8215, Seoul

Site No. 8223, Seoul

Site No. 8210, Suwon

Site No. 8217, Ulsan

Site No. 8305, Kaohsiung City

Site No. 8307, Linkou District

Site No. 8306, Taichung

Site No. 8302, Tainan City

Site No. 8301, Taipei

Site No. 8303, Taipei

Site No. 8502, Bangkok

Site No. 8505, Bangkok

Site No. 8503, Chiang Mai

Site No. 8507, Hat Yai

Site No. 8501, Khon Kaen

Site No. 8506, Phitsanulok

Site No. 9501, Birmingham

Site No. 9505, Guildford

Site No. 9503, Leeds

Site No. 9502, London

Site No. 9504, London

Site No. 9506, London

T6G 2B7

University of Alberta Hospital, Edmonton

L8V 1C3

Juravinski Cancer Centre, Hamilton

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

All Listed Sponsors
lead

SillaJen, Inc.

INDUSTRY

NCT02562755 - Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone | Biotech Hunter | Biotech Hunter