drugset / Trial / NCT05033522

Immunotherapy for Advanced Liver Cancer

NCT05033522

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

EvaluationDrugModalityDoseRoute
Subject AlloStim Cell therapy 0.5 ml Intravenous
Subject AlloStim Cell therapy 3 ml Intravenous
Comparator Lenvatinib Small molecule
Comparator Sorafenib Small molecule