Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Lenvatinib

Immunomodulating Agents

Liver Extracts

Muromonab-CD3

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

AlloStim® is a formulation of living allogeneic Th1-like cells with anti-CD3/CD28 microbeads attached derived from precursors purified from healthy screened blood donors that are differentiated and expanded ex-vivo. AlloStim® is formulated at 10-7 cells/ml in 0.5ml for ID administration and 3ml for IV administration

Physician's Choice is sorafenib or levantinib or FOLFOX4 monotherapy

3 cycles of intradermal and intravenous administrations

AlloStim® immunotherapy

Comparative arm: Physician Choice of FOLFOX4 chemotherapy

FOLFOX regimen

Comparative arm: Physician Choice of Sorafenib

Comparative Arm: Physician's Choice of Levantinib

Preechanoot Aimruen

Kanokwan Pornprasit

Farah Amalina Binti Mohamed Affandi, RN

Heng Chin Fong, MD

Siti Zurairah binti Md Saif, RN

Sen Chun Lim, MD

Ms Kamila, RN

Datuk Dr Muhammad Radzi Abu Hassan, MD

Mohd Khirul

Kananathan Ratnavelu, MD

Dharmaratnam Jeyandran, MD

Saranya Sarapat (คุณปุ้ย), RN

Krittiya Korphaisarn, MD

Nopparat Natekaew (น้องนุ๊ก), RN

Abhasnee Sobhonslidsuk, MD

Keson Trakunram, RN

Arunee Dechaphunkul, MD

Prathana Anekpunyakul, RN

Ekawee Sripariwuth, MD

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.

A multi-national, randomized, controlled trial (RCT) with multiple sites selected in Asia (Malaysia and Thailand). Subjects with no prior treatments for BCLC stage C disease and presenting with Child-Pugh class A or B liver reserve to be randomized 2:1 to AlloStim® vs. Physician's Choice (PC). PC to be declared prior to randomization. PC allowed to be either sorafenib, levantinib or FOLFOX4.

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 with an improved quality of life compared to approved first line therapy.

Subjects are randomized 2:1 to experimental vs physician's choice. A two-sided logrank test with an overall sample size of 130 subjects (43 in the control group and 87 in the treatment group) achieves 80% power to detect at a 0.05 significance level a hazard ratio of 0.56 when the control group median survival is 6.5 months. A total of 150 subjects are planned to be accrued.

The investigator and subjects will be informed of the treatment group to which the subject has been randomized.

Immunotherapy for Advanced Liver Cancer

Phase II/III Randomized, Controlled Clinical Study of AlloStim(R) vs Physician's Choice in Asian Subjects With Advanced Hepatocellular Carcinoma

using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy-Hepatobiliary Questionnaire (FACT-Hep)

To assess time to symptomatic progression (TTSP)

Mirror Biologics, Inc.

Immunovative Therapies, Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Immunotherapy for Advanced Liver Cancer	NCT05033522	Hepatocellular ...	AlloStim® immun... FOLFOX regimen Sorafenib Lenvatinib	18 Years - 80 Years	Immunovative Therapies, Ltd.
Immunotherapy for Advanced Liver Cancer	NCT05033522	Hepatocellular ...	AlloStim® immun... FOLFOX regimen Sorafenib Lenvatinib	18 Years - 80 Years	Immunovative Therapies, Ltd.

Spots Global Cancer Trial Database for allostim® immunotherapy