drugset / Trial / NCT05033522
Immunotherapy for Advanced Liver Cancer
RandomizedParallel-groupSingle-blindTreatment
Summary
This is a randomized, controlled multi-site, multi-national clinical trial conducted in Thailand and Malaysia for Asian adults (males or females), 18 years of age and older presenting with advanced HCC (BCLC stage C) including subjects with macrovascular involvement and/or extrahepatic spread (not eligible for TACE, surgery or locoregional treatment) with Child-Pugh stage A or B liver function. 150 subjects will be randomized 2:1 to AlloStim® immunotherapy vs Physician's Choice of Sorafenib, Lenvatinib or FOLFOX4.
Timeline
- Start
- 2023-08-01
- Primary completion
- 2026-11-01
- Completion
- 2026-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AlloStim | Cell therapy | 0.5 ml | Intravenous |
| Subject | AlloStim | Cell therapy | 3 ml | Intravenous |
| Comparator | Lenvatinib | Small molecule | — | — |
| Comparator | Sorafenib | Small molecule | — | — |