Advanced HCC patients Immunotherapy,
Conditions
Interventions
AlloStim® (ID): in 1 ml of formulation buffer containing 1 x 107 cells per ml placed in a 3 ml syringe for ID injection.
AlloStim® (IV): in 3 ml of formulation buffer containing 1 x 107 cells per
Experimental Biological/Vaccine
AlloStim (R)
Sponsors
Immunovative Therapies Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Males and females who are at least 18 years of age at time of enrollment 2. With or without positive HBV and/or HCV 3. BCLC stage C disease with no prior treatment or no longer benefiting from prior locoregional therapy 4. With or without extrahepatic disease and with or without macrovascular invasion 5. Child-Pugh Class A 6. Performance status: ECOG 10.0 g/dl -Platelet count > 75,000/μl -ALT and AST < 5 x ULN -Alkaline phosphatase < 4 x ULN -Serum creatinine < 1.5 10. Women of child-bearing potential: negative pregnancy test 11. Patients of child producing potential: usage of contraception or avoidance of pregnancy measures while enrolled on study 12. Ability to understand the study, its inherent risks, side effects and potential benefits and ability to give written informed consent to participate
Exclusion criteria
Exclusion criteria: 1. Moderate uncontrolled or severe ascites (+3 on Child-Pugh calculator) 2. Clinical symptoms of encephalopathy 3. INR > 1.5 4. Unable to tolerate radiological contrast dye 5. Prior first line or second line treatment for BCLC stage C disease, including checkpoint blockade, sorafenib, levantinib or regorafinib or other experimental or off-label treatments or procedures 6. Any autoimmune disorder 7. Any clinical condition requiring systemic steroids or any current immunosuppressive therapy 8. HIV positive 9. History of cardiac disease: congestive heart failure > NYHA class 2; cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or Digoxin are permitted) or uncontrolled hypertension 10. Active clinically serious infections (> grade 2 CTCAE version 4.03) 11. History of organ transplant or tissue allograft 12. Uncontrolled concurrent serious medical or psychiatric illness 13. Clinically apparent central nervous system metastases or carcinomatous meningitis 14. History of blood transfusion reactions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival weekly Survival follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression weekly Survival follow up | — |
Countries
Thailand
Contacts
Public ContactMichael Har-Noy
Immunovative Therapies Ltd
Outcome results
None listed