MedTrace Logo

Immunotherapy for Advanced Liver Cancer

NCT05033522 · Status: SUSPENDED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-10-23

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

AlloStim® immunotherapy

3 cycles of intradermal and intravenous administrations

DRUG

FOLFOX regimen

Comparative arm: Physician Choice of FOLFOX4 chemotherapy

DRUG

Sorafenib

Comparative arm: Physician Choice of Sorafenib

DRUG

Lenvatinib

Comparative Arm: Physician's Choice of Levantinib

Sponsors & Collaborators

  • Immunovative (Thailand) Co., Ltd

    collaborator UNKNOWN

  • Mirror Biologics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2026-11-01
Completion
2026-12-01
FDA Drug
Yes

Countries

  • Malaysia
  • Thailand

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05033522 on ClinicalTrials.gov