Immunotherapy for Advanced Liver Cancer

• Status: Not yet recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, controlled multi-site, multi-national clinical trial conducted in Thailand and Malaysia for naïve Asian adults (males or females), 18 years of age and older presenting with advanced HCC (BCLC stage C) including subjects with vascular involvement and/or extrahepatic spread (not eligible for TACE, surgery or locoregional treatment) with Child-Pugh stage A or B liver function and either unable to assess, or not eligible for, sorafenib first line treatment. 180 subjects will be randomized 2:1 to AlloStim® immunotherapy vs Physician's Choice of Best Supportive Care or FOLFOX4 chemotherapy.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Immunovative Therapies, Ltd.
• Collaborator: Mirror Biologics, Inc.

Criteria

Inclusion Criteria:

1. Males and females who are at least 18 years of age at time of enrollment

2. Histologically or cytologically documented advanced HCC (BCLC stage C) disease at diagnosis.

3. No prior HCC treatment. (exclude if prior local therapy, such as surgery, radiation, TACE, RFA, ETOH ablation, cryoablation)

4. Child-Pugh Class A and not able to assess sorafenib or Child-Pugh Class B and not eligible for sorafenib

5. Performance status: ECOG < 2 with no deterioration over the previous 2 weeks

6. With or without positive HBV and/or HCV

7. With or without extrahepatic disease and with or without macrovascular invasion

8. Measurable enhancing disease in liver with at least one target lesion evaluable by mRECIST

9. Adequate hematological, liver and renal function as assessed by the following:

• Hemoglobin > 10.0 g/dl

• Platelet count > 75,000/μl

• ALT and AST < 5.0 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:

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. Child-Pugh liver function combined score >9 (Class C or Class D)

3. Moderate uncontrolled or severe ascites (+3 on Child-Pugh calculator)

4. Clinical symptoms of hepatic decompensation or presence of hepatic encephalopathy

5. Severe stomach/esophageal varices requiring interventional treatment.

6. Unable to tolerate radiological contrast dye

7. Any prior experimental, approved or off-label treatment for HCC (including levantinib, nivolumab, duvalumab, tremelimumab, brivananib, cabozantinib or ramucircumab) or any approved or experimental procedures such as surgery, radiation or ablation.

8. Enrollment in any previous clinical trial for HCC

9. Any history of autoimmune disorder (type I, insulin-dependent diabetes allowed)

10. History of COPD or oxygen saturation <92% at room air

11. Any clinical condition requiring systemic steroids (inhaled steroids allowed) or any current immunosuppressive therapy or anti-epileptic drug therapy.

12. Known history of HIV infection

13. Clinically significant gastrointestinal bleeding within 30 days prior to study entry

14. History of cardiac disease: congestive heart failure > NYHA class 2; cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or Digoxin are permitted)

15. Uncontrolled hypertension (SBP >150 or DBP>90).

16. Active clinically serious infections (> grade 2 CTCAE version 5.0)

17. History of organ transplant or tissue allograft

18. Uncontrolled concurrent serious medical or psychiatric illness

19. Clinically apparent central nervous system metastases or carcinomatous meningitis

20. History of drug abuse or current alcohol abuse

21. History of blood transfusion reactions

22. Pregnant or lactating women