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Clinical Trial 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.

Clinical Trial Description

A multi-national, randomized, controlled trial (RCT) with multiple sites selected in Asia (Malaysia and Thailand). Subjects with no prior treatments presenting with BCLC stage C disease and Child-Pugh class A or B liver reserve without access to sorafenib to be randomized 2:1 to AlloStim® vs. Physician's Choice (PC). PC to be declared prior to randomization. PC allowed to be either best supportive care (BSC) or best supportive care with palliative chemotherapy (FOLFOX4). Prior or planned treatment with active systemic therapies (e.g., levantinib, nivolumab, duvalumab, tremelimumab, brivananib, cabozantinib and ramucircumab) or procedures (e.g., TACE, RFA, ETOH ablation, surgery, radiation) excluded. The world incidence of hepatocellular carcinoma (HCC) is highest in East and South East Asia, with nearly half of the all HCC cases and deaths globally occurring in China. In Asian countries, the main treatment options for early or intermediate HCC (BCLC class A and B) include surgical resection, ablation (e.g., RFA, ETOH, cryoablation), transarterial chemoembolization (TACE), radiation or systemic chemotherapy depending on liver function status. However, in the Asian-Pacific region it is estimated that up to 80% of patients present with unresectable, advanced HCC (BCLC Stage C) that are not eligible for locoregional therapy, surgery or TACE due to tumor size and/or vascular involvement. For these patients, the standard of care for over a decade has been sorafenib (Bayer, A.G.), a oral kinase inhibitor based on the results of a RCT (SHARP study) of 602 patients randomized to sorafenib vs. placebo. Median overall survival (OS) was 10.7 months for sorafenib and 7.9 months for placebo (p<0.05). The SHARP study included a Western population. A separate study in Asian patients (226 patients from China, South Korea and Taiwan) comparing sorafenib to placebo (Sorafenib-AP study) demonstrated a OS of 6.5 months for sorafenib compared to 4.2 months for placebo (p<0.05). The placebo OS difference between Asian and Western patients (4.2mo vs 7.9 mo) suggests a difference in the disease characteristics in the Asian population. One significant difference is that the Asian population has an increased prevalence of HBV compared to Western population which may contribute to the increased incidence of HCC and worse OS outcomes observed in Asian patients compared to Western patients. In Thailand and Malaysia sorafenib is not available to a majority of the population presenting with advanced HCC, both due to cost and toxicity profile. This study is designed to evaluate whether AlloStim ® immunotherapy will provide a survival benefit to this population. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05033522
Study type Interventional
Source Immunovative Therapies, Ltd.
Contact Christophe Tournerie, MD
Phone +65 64365501
Email [email protected]
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date February 2022
Completion date February 2025

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