A Phase 2b Study of Recombinant Vaccinia Virus to Treat Advanced Liver Cancer

Conditions: Advanced hepatocellular carcinoma
MedDRA version: 14.0Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-000051-16-ES

Lead Sponsor: Jennerex, Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 120

Inclusion Criteria

- Advanced HCC: patients are not eligible for, or had disease progression after, local-regional therapy (e.g. surgery, TACE, RFA, ethanol injection)
- Histologic or cytologic confirmation of primary hepatocellular carcinoma (HCC)
- Previously treated with sorafenib for ? 14 days and has discontinued sorafenib treatment at least 14 days prior to randomization due to either intolerance or radiographic progression
- Received sorafenib as the most recent therapeutic intervention
- ECOG performance status 0, 1 or 2
?Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

- Major surgery within 28 days of randomization or subcutaneous venous access device placement within 7 days prior to randomization
- Locoregional therapy within 28 days prior to randomization
- Received sorafenib within 14 days prior to randomization
- Received systemic therapy other than sorafenib within 28 days of randomization
- Prior treatment with JX-594
- Platelet count < 50,000 PLT/ mm3
- Total white blood cell count < 2,000 cells/mm3
- Hematocrit < 30% and/or Hemoglobin < 10 g/dL
- Known significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication
- Severe or unstable cardiac disease
- Viable CNS malignancy associated with clinical symptoms
- Pregnant or nursing an infant

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Determine and compare overall survival (OS) for patients receiving JX-594 plus best supportive care (BSC) (Arm A) versus those receiving BSC (Arm B) in patients with advanced hepatocellular carcinoma (HCC) who have failed sorafenib treatment.;Secondary Objective: - Determine and compare time-to-tumor-progression (TTP) for Arm A versus Arm B based on modified RECIST (mRECIST) for HCC.<br>- Determine the response rate for Arm A compared with Arm B based on mRECIST for HCC.<br>- Determine time-to-symptomatic progression (TSP) for Arm A compared with Arm B.<br>- Determine the Quality of Life (QoL) of patients treated in Arm A compared with Arm B.<br>- Determine the safety and tolerability of JX-594 plus BSC (Arm A) compared to BSC (Arm B).;Primary end point(s): Overall Survival;Timepoint(s) of evaluation of this end point: CT scan every six weeks until progression or death

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Time-to-tumor progression, tumor response, time-to-symptomatic-progression duration, change in quality of life, safety and toxicity.;Timepoint(s) of evaluation of this end point: - Time to Tumor Progression: CT scan every six weeks until progression or death, assessed up to 21 months (average)<br>- Quality of Life: assessed up to 21 months (average)<br>- Tumor Response: CT scan every 6 weeks until progression or death, assessed up to 21 months (average)<br>- Safety profile of JX594: assessed up to 21 months (average)<br>- Time-to-symptomatic-progression: assessed up to 21 months (average)