A Phase II/III Randomized, Controlled Clinical Study of AlloStim® vs. Physician’s Choice in Asian Subjects with Advanced Hepatocellular Carcinoma.

Phase 2

• Conditions: Advanced HCC; Immunotherapy

• Registration Number: TCTR20201208004
• Lead Sponsor: Dr. Michael Hay-Nor

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-08
• Study Completion: 2022-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Male or Female ≥18yo and ≤ 75yo with histologically or radiologically confirmed hepatocellular carcinoma (HCC).
1.1 Non-resectable disease
1.2 not amenable to local therapy with curative intent (surgery, radiation, ablation,
TACE)
1.3 With or without positive Hepatitis B Virus HBV and/or Hepatitis C Virus (HCV)
2. BCLC stage C disease with no prior treatment
2.1 Not eligible for, or unable to obtain access to first line: sorafenib or lenvatinib.
2.2 With or without extrahepatic disease
3. Child-Pugh Class A or Class B
3.1 with or without macrovascular invasion (MVI)
4. Performance status: Eastern Cooperative Oncology Group (ECOG) 0-1
4.1 with no deterioration over the previous 2 weeks
5. Measurable enhancing disease in liver (mRECIST)
6. Adequate liver and renal function as assessed by the following:
6.1 Hemoglobin > 10.0 g/dl
6.2 Platelet count > 75,000/μl
6.3 ALT and AST < 5 x ULN
6.4 Alkaline phosphatase < 4 x ULN
6.5 Serum creatinine < 1.5
7. Women of child-bearing potential o negative pregnancy test
7.1 usage of contraception or avoidance of pregnancy measures while enrolled on study
8. Ability to regularly visit the research institutions per protocol for related tests, evaluations, and management during the study period.
9. Ability to understand the study, its inherent risks, side effects and potential benefits and ability to give written informed consent to participate
9.1 Travel stipend allowed

Exclusion Criteria

1.Any prior cancer diagnosis (other than cured basal cell carcinoma, head and neck carcinoma in-situ, or superficial Ta, Tis, T1 bladder cancer) or concurrent cancer histologically different than HCC (e.g., cholangiocarcinoma).
2. Prior exposure to checkpoint inhibitors (PD-1/PD-L1 or CTLA4)
3. Enrollment in any previous clinical trial for HCC
4. Received or undergone any prior procedures, medications or treatments for HCC
5. Moderate uncontrolled or severe ascites (+3 on Child-Pugh calculator)
6. International normalized ratio (INR) >1.7 (+2 or +3 on Child-Pugh calculator)
7. Clinical symptoms of hepatic decompensation or presence of hepatic encephalopathy
7.1 >grade 1 (+2 or +3 on Child-Pugh calculator)
8. Score of >9 on Child-Pugh calculator (class C)
9. Severe stomach/esophageal varices requiring interventional treatment.
10. Clinically significant gastrointestinal bleeding within 30 days prior to study entry
11. History of Chronic obstructive pulmonary disease (COPD) or oxygen saturation <95% on room air
12. Unable to tolerate contrast dye
13. History of any autoimmune (including: rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, ankylosing spondylitis, Crohn’s disease, Addison’s disease, Grave’s disease, Sjogren’s syndrome, myasthenia gravis and autoimmune vasculitis, autoimmune hepatitis, uveitis) o Type I diabetes allowed
13.1 If no active disease in the last 5 years may be included but only after consultation with the study physician and medical monitor.
13.2 Patients with celiac disease controlled by diet alone allowed
14. Current chronic inflammatory disorder (including: inflammatory bowel disease, colitis, Hashimoto’s thyroiditis)
15. Any clinical condition requiring systemic steroids or current immunosuppressive therapy o Inhaled steroids allowed
16. Known history of HIV positive
17. History of cardiac disease: congestive heart failure > New York Heart Association (NYHA) class 2; cardiac arrhythmias requiring anti-arrhythmic therapy o beta blockers or Digoxin are permitted
18. History of stroke or pulmonary embolism within 1 year of accrual
19. Active clinically serious infections (> grade 2 Common Terminology Criteria for Adverse Events (CTCAE) version 5)
20. History of organ or tissue allograft
21. Uncontrolled concurrent serious medical or psychiatric illness
22. Clinically apparent central nervous system metastases or carcinomatous meningitis
23. History of blood transfusion reactions

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall survival weekly Survival follow up

Secondary Outcome Measures

Name	Time	Method
Quality of life weekly Questionnnaire