Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone
- Conditions
- Hepatocellular Carcinoma (HCC)
- Interventions
- Biological: Pexastimogene Devacirepvec (Pexa Vec)
- Registration Number
- NCT02562755
- Lead Sponsor
- SillaJen, Inc.
- Brief Summary
This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy.
- Detailed Description
This is a multi-center, randomized, open-label, Phase 3 study comparing Pexa Vec followed by sorafenib versus sorafenib in patients with advanced HCC without prior systemic therapy.
A total of 459 patients were randomly assigned to 2 treatment arms- 234 patients in the Pexa-Vec followed by sorafenib treatment group and 225 patients in the sorafenib only treatment group.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 459
- Histological/cytological diagnosis of primary HCC
- Advanced stage HCC (Barcelona Clinic Liver Cancer [BCLC] Stage C or B per American Association for the Study of Liver Disease [AASLD] guidelines)
- At least one measurable viable tumor in the liver, ≥1 cm longest diameter (LD), using a dynamic imaging technique (arterial phase of triphasic computerized tomography [CT] scan, or dynamic contrast-enhanced magnetic resonance imaging [MRI]), and injectable under imaging-guidance (CT and/or ultrasound)
- Child-Pugh Class A
- Performance status 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Adequate hematological, hepatic, and renal function:
- Additional inclusion criteria exist
- Histological diagnosis of cholangiocarcinoma, hepatocholangiocarcinoma, fibrolamellar carcinoma and hepatoblastoma
- Symptomatic cardiovascular disease, including but not limited to significant coronary artery disease (e.g., requiring angioplasty or stenting) or congestive heart failure within the preceding 12 months
- Current or past history of cardiovascular disease (e.g.. past history of myocardial infarction, ischemic cardiomyopathy) unless cardiology consultation and clearance has been obtained for study participation
- History of moderate or severe ascites, bleeding esophageal varices, hepatic encephalopathy or pleural effusions related to liver insufficiency within 6 months of screening
- Bulky disease patients - tumors encompassing >50% of the liver volume and / or inferior vena cava invasion
- Known significant immunodeficiency due to underlying illness (e.g., HIV/AIDS) and/or immune-suppressive medication including high-dose corticosteroids
- Ongoing severe inflammatory skin condition (as determined by the Investigator) requiring medical treatment
- History of severe eczema (as determined by the Investigator) requiring medical treatment
- Additional exclusion criteria exist
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pexa-Vec followed by Sorafenib Pexastimogene Devacirepvec (Pexa Vec) Pexa-Vec (pexastimogene devacirepvec) will be administered as 3 bi-weekly intratumoral (IT) injections of 1e9 pfu at day 1 and weeks 2 and 4, followed by sorafenib at Week 6. Pexa-Vec followed by Sorafenib Sorafenib Pexa-Vec (pexastimogene devacirepvec) will be administered as 3 bi-weekly intratumoral (IT) injections of 1e9 pfu at day 1 and weeks 2 and 4, followed by sorafenib at Week 6. Sorafenib Sorafenib Sorafenib (400 mg twice daily) begins on Day 1.
- Primary Outcome Measures
Name Time Method Overall Response Rate (ORR) From date of randomization to the date of first documented radiographic tumor progression up to 53 months Percentage of participants who showed overall response during their participation in the study. Per Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) and assessed by tri-phasic contrast enhanced CT: Complete Response (CR), Disappearance of intratumoral enhancing area; Partial Response (PR), \>=30% decrease in the sum of the diameters of enhancing area; Overall Response (OR) = CR + PR.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (142)
Site No. 8306
🇨🇳Taichung, Taiwan
Site No. 8505
🇹🇭Bangkok, Thailand
Site No. 8503
🇹🇭Chiang Mai, Thailand
Site No. 8301
🇨🇳Taipei, Taiwan
Site No. 8303
🇨🇳Taipei, Taiwan
Site No. 8507
🇹🇭Hat Yai, Thailand
Site No. 8501
🇹🇭Khon Kaen, Thailand
Site No. 8506
🇹🇭Phitsanulok, Thailand
Site No. 8414
🇦🇺Heidelberg, Australia
Site 9012
🇫🇷Montpellier, France
Site No. 8211
🇰🇷Bucheon, Korea, Republic of
Site No. 8403
🇦🇺Brisbane, Australia
Mayo Clinic Arizona
🇺🇸Scottsdale, Arizona, United States
Site No. 8401
🇦🇺Camperdown, Australia
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
Site No. 8406
🇦🇺Concord, Australia
University of Florida Shands Hospital
🇺🇸Gainesville, Florida, United States
Billings Clinic
🇺🇸Billings, Montana, United States
Site No. 8411
🇦🇺Melbourne, Australia
Site No. 8402
🇦🇺Parkville, Australia
University of Kansas Cancer Center
🇺🇸Kansas City, Kansas, United States
Site No. 9014
🇫🇷Paris, France
Site No. 8412
🇦🇺Adelaide, Australia
Site No. 8405
🇦🇺Footscray, Australia
Stanford University School of Medicine
🇺🇸Palo Alto, California, United States
Site No. 8821
🇨🇳Changsha, China
Site No. 8407
🇦🇺Clayton, Australia
Site No. 9204
🇮🇹Napoli, Italy
Site No. 8409
🇦🇺Adelaide, Australia
Site No. 9005
🇫🇷Bordeaux, France
Site No. 9113
🇩🇪Bonn, Germany
Site No. 9110
🇩🇪Ulm, Germany
Site No. 9707
🇮🇱Afula, Israel
Site No. 9702
🇮🇱Haifa, Israel
Site No. 9703
🇮🇱Ramat-Gan, Israel
Site No. 9402
🇵🇹Porto, Portugal
Site No. 8305
🇨🇳Kaohsiung, Taiwan
Site 8820
🇨🇳Fuzhou, China
Site 9704
🇮🇱Haifa, Israel
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Site No. 8205
🇰🇷Seoul, Korea, Republic of
Site No. 9706
🇮🇱Tel Aviv, Israel
Site No. 9403
🇵🇹Lisboa, Portugal
Site No. 9106
🇩🇪Hamburg, Germany
Site 8224
🇰🇷Goyang, Korea, Republic of
Site 8216
🇰🇷Daegu, Korea, Republic of
Site No. 9705
🇮🇱Jerusalem, Israel
Site No. 9501
🇬🇧Birmingham, United Kingdom
Site No. 9505
🇬🇧Guildford, United Kingdom
Site No. 8701
🇸🇬Singapore, Singapore
Site No. 8307
🇨🇳Linkou, Taiwan
Site No. 9201
🇮🇹Palermo, Italy
Site No. 9203
🇮🇹Parma, Italy
Site No. 8222
🇰🇷Seongnam, Korea, Republic of
Site No. 9111
🇩🇪Aachen, Germany
Site No. 9009
🇫🇷Vandœuvre-lès-Nancy, France
Site No 9105
🇩🇪Hannöver, Germany
Site No. 9101
🇩🇪Mainz, Germany
Site No. 8213
🇰🇷Daegu, Korea, Republic of
Site No. 9405
🇵🇹Coimbra, Portugal
Site 8702
🇸🇬Singapore, Singapore
Site No. 8502
🇹🇭Bangkok, Thailand
Site No.9205
🇮🇹Modena, Italy
Site No. 9112
🇩🇪Heidelberg, Germany
Site No. 9102
🇩🇪München, Germany
Site No. 9104
🇩🇪Tübingen, Germany
Site No. 8207
🇰🇷Daegu, Korea, Republic of
Site No. 9404
🇵🇹Coimbra, Portugal
Site No. 8302
🇨🇳Tainan City, Taiwan
Site No. 8215
🇰🇷Seoul, Korea, Republic of
Site No.8815
🇨🇳Hefei, China
Site 8832
🇨🇳Hangzhou, China
Site 8833
🇨🇳Qingdao, China
Site 8806
🇨🇳Shanghai, China
Site No. 8823
🇨🇳Xi'an, China
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Site No. 9013
🇫🇷Bondy, France
Site No. 8202
🇰🇷Seoul, Korea, Republic of
Site No. 9502
🇬🇧London, United Kingdom
Site No. 9503
🇬🇧Leeds, United Kingdom
Site No. 9007
🇫🇷Paris, France
Site No. 9008
🇫🇷Nantes, France
Site No. 9011
🇫🇷Rennes, France
Auckland City Hospital
🇳🇿Auckland, New Zealand
Site No. 9504
🇬🇧London, United Kingdom
Site No. 9006
🇫🇷Lille, France
Site No. 8201
🇰🇷Busan, Korea, Republic of
Site No. 8220
🇰🇷Daegu, Korea, Republic of
Site No. 8212
🇰🇷Seoul, Korea, Republic of
UC Irvine Medical Center
🇺🇸Orange, California, United States
Tulane University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
St. Joseph's Hospital
🇺🇸Paterson, New Jersey, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Site No. 8408
🇦🇺Fitzroy, Australia
Site No. 8413
🇦🇺Sydney, Australia
Site No. 8415
🇦🇺Perth, Australia
Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Site 8829
🇨🇳Changchun, China
Site 8811
🇨🇳Fuzhou, China
Site No.8816
🇨🇳Guangdong, China
Site 8827
🇨🇳Guangzhou, China
Site No.8828
🇨🇳Guangzhou, China
Site 8805
🇨🇳Hefei, China
Site No. 8802
🇨🇳Harbin, China
Site No. 8808
🇨🇳Hefei, China
Site 8822
🇨🇳Shanghai, China
Site No. 8825
🇨🇳Xi'an, China
Site 8831
🇨🇳Shanghai, China
Site No. 9003
🇫🇷Créteil, France
Site No. 9010
🇫🇷Nice, France
Site No. 9001
🇫🇷Strasbourg, France
Site No. 9002
🇫🇷Toulouse, France
Site No. 9109
🇩🇪Dresden, Germany
Site No. 9108
🇩🇪Frankfurt am Main, Germany
Site No. 8208
🇰🇷Ansan, Korea, Republic of
Site No. 8221
🇰🇷Jinju-si, Korea, Republic of
Site No. 8218
🇰🇷Pusan, Korea, Republic of
Site No. 8203
🇰🇷Seoul, Korea, Republic of
Site No. 8219
🇰🇷Seongnam-si, Korea, Republic of
Site No. 8209
🇰🇷Seoul, Korea, Republic of
Site No. 8210
🇰🇷Suwon, Korea, Republic of
Site No. 8223
🇰🇷Seoul, Korea, Republic of
Site No. 8217
🇰🇷Ulsan, Korea, Republic of
Site No. 8902
🇳🇿Christchurch, New Zealand
Site 8703
🇸🇬Singapore, Singapore
Site No. 9401
🇵🇹Porto, Portugal
Site No. 9506
🇬🇧London, United Kingdom
University of Alabama
🇺🇸Birmingham, Alabama, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Mercy Medical Center, Inc.
🇺🇸Baltimore, Maryland, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Kansas City Research Institute
🇺🇸Kansas City, Missouri, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Hospital of The University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Benaroya Research Institute at Virginia Mason Hospital
🇺🇸Seattle, Washington, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
Site No. 8801
🇨🇳Nanjing, China
Site No. 8601
🇭🇰Hong Kong, Hong Kong