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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02562755




Registration number
NCT02562755
Ethics application status
Date submitted
24/09/2015
Date registered
29/09/2015

Titles & IDs
Public title
Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone
Scientific title
A Phase 3 Randomized, Open-Label Study Comparing Pexa Vec (Vaccinia GM CSF / Thymidine Kinase-Deactivated Virus) Followed by Sorafenib Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC) Without Prior Systemic Therapy
Secondary ID [1] 0 0
JX594-HEP024
Universal Trial Number (UTN)
Trial acronym
PHOCUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatocellular Carcinoma (HCC) 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Pexastimogene Devacirepvec (Pexa Vec)
Treatment: Drugs - Sorafenib

Experimental: Pexa-Vec followed by 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.

Active comparator: Sorafenib - Sorafenib (400 mg twice daily) begins on Day 1.


Treatment: Other: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
From date of randomization to the date of first documented radiographic tumor progression up to 53 months

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2020
Sample size
Target
Accrual to date
Final
459
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site No. 8409 - Adelaide
Recruitment hospital [2] 0 0
Site No. 8412 - Adelaide
Recruitment hospital [3] 0 0
Site No. 8403 - Brisbane
Recruitment hospital [4] 0 0
Site No. 8401 - Camperdown
Recruitment hospital [5] 0 0
Site No. 8407 - Clayton
Recruitment hospital [6] 0 0
Site No. 8406 - Concord
Recruitment hospital [7] 0 0
Site No. 8408 - Fitzroy
Recruitment hospital [8] 0 0
Site No. 8405 - Footscray
Recruitment hospital [9] 0 0
Site No. 8414 - Heidelberg
Recruitment hospital [10] 0 0
Site No. 8411 - Melbourne
Recruitment hospital [11] 0 0
Site No. 8402 - Parkville
Recruitment hospital [12] 0 0
Site No. 8415 - Perth
Recruitment hospital [13] 0 0
Site No. 8413 - Sydney
Recruitment postcode(s) [1] 0 0
- Adelaide
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- Brisbane
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- Camperdown
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- Clayton
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- Concord
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- Fitzroy
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- Footscray
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- Heidelberg
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- Melbourne
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- Parkville
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- Perth
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- Sydney
Recruitment outside Australia
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Alabama
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Guangzhou
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Hangzhou
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China
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Harbin
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Hefei
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China
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Nanjing
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China
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Qingdao
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China
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Shanghai
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China
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Xi'an
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Bondy
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Ulm
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Pusan
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Seongnam
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Seoul
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Porto
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Singapore
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Taiwan
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Kaohsiung
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Linkou
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Taichung
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Taipei
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Chiang Mai
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Hat Yai
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Khon Kaen
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Phitsanulok
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United Kingdom
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Birmingham
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Guildford
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Leeds
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
SillaJen, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
SillaJen Medical
Address 0 0
SillaJen, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02562755