Hepatocellular CarcinomaPhase 2/3ALIVENCT05033522
Immunotherapy for Advanced Liver Cancer
A Phase 2/3 study testing AlloStim® immunotherapy, FOLFOX regimen and Sorafenib in people with Hepatocellular Carcinoma, run by Mirror Biologics, Inc. at 8 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- AlloStim® immunotherapy, FOLFOX regimen and Sorafenib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 1 Aug 2023to 1 Dec 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females who are at least 18 years of age at time of enrollment
- Histologically or cytologically documented advanced HCC (BCLC stage C) disease at diagnosis.
- No prior treatment for BCLC class C disease.
- Child-Pugh Class A or subset of Child-Pugh Class B
- Performance status: ECOG < 2 with no deterioration over the previous 2 weeks
- With or without positive HBV and/or HCV
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- With or without extrahepatic disease and with or without macrovascular invasion
- Measurable enhancing disease in liver with at least one target lesion evaluable by mRECIST
- Adequate hematological, liver and renal function as assessed by the following:
- Hemoglobin > 10.0 g/dl
- Platelet count > 75,000/μl
- ALT and AST < 5.0 x ULN
- Serum creatinine < 1.5
- Women of child-bearing potential: negative pregnancy test
- Patients of child producing potential: usage of contraception or avoidance of pregnancy measures while enrolled on study
- Ability to understand the study, its inherent risks, side effects and potential benefits and ability to give written informed consent to participate
Who cannot join
- Any prior cancer diagnosis (other than cured basal cell carcinoma, head and neck carcinoma in-situ, or superficial Ta, Tis, T1 bladder cancer) or concurrent cancer histologically different than HCC (e.g., cholangiocarcinoma).
- Child-Pugh liver function combined score >9 (Class C or Class D)
- Moderate uncontrolled or severe ascites (+3 on Child-Pugh calculator)
- Clinical symptoms of hepatic decompensation or presence of hepatic encephalopathy
- Severe stomach/esophageal varices requiring interventional treatment.
- Unable to tolerate radiological contrast dye
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- Any prior experimental, approved or off-label treatment for HCC (including levantinib, nivolumab, duvalumab, tremelimumab, brivananib, cabozantinib or ramucircumab) or any approved or experimental procedures such as surgery, radiation or ablation.
- Enrollment in any previous clinical trial for HCC
- Any history of autoimmune disorder (type I, insulin-dependent diabetes allowed)
- History of COPD or oxygen saturation <92% at room air
- Any clinical condition requiring systemic steroids (inhaled steroids allowed) or any current immunosuppressive therapy or anti-epileptic drug therapy.
- Known history of HIV infection
- Clinically significant gastrointestinal bleeding within 30 days prior to study entry
- History of cardiac disease: congestive heart failure > NYHA class 2; cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or Digoxin are permitted)
- Uncontrolled hypertension (SBP >150 or DBP>90).
- Active clinically serious infections (> grade 2 CTCAE version 5.0)
- History of organ transplant or tissue allograft
- Uncontrolled concurrent serious medical or psychiatric illness
- Clinically apparent central nervous system metastases or carcinomatous meningitis
- History of drug abuse or current alcohol abuse
- History of blood transfusion reactions
- Pregnant or lactating women
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Thailand5 sites
Siriraj Hospital
Bangkok Noi, Bangkok, 10700
Chiangmai University
Chiang Mai
Prince of Songkla University (Songklanagarind Hospital)
Hat Yai, Changwat Songkhla, 90110
Songklanagarind Hospital
Khon Kaen
Naresuan University Hospital
Phitsanulok, Tha Pho, 65000
Malaysia3 sites
Sultanah Bahiyah Hospital
Alor Star, Kedah, 05460
Sultan Ismail Hospital
Johor Bahru, Johor, 81100
Columbia Asia Bukit Rimau
Shah Alam, Selangor, 40460
About this study
Official title: Phase II/III Randomized, Controlled Clinical Study of AlloStim(R) vs Physician's Choice in Asian Subjects With Advanced Hepatocellular Carcinoma
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.
Read the detailed description
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- AlloStim® immunotherapy, FOLFOX regimen, Sorafenib, Lenvatinib
- Keywords
- liver cancer, immunotherapy, Thailand, Malaysia
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlloStim® immunotherapyBiological
3 cycles of intradermal and intravenous administrations
FOLFOX regimenDrug
Also called Physician Choice FOLFOX4
Comparative arm: Physician Choice of FOLFOX4 chemotherapy
SorafenibDrug
Also called Sorafenib Physician's Choice
Comparative arm: Physician Choice of Sorafenib
LenvatinibDrug
Also called Levantinib Physician's Choice
Comparative Arm: Physician's Choice of Levantinib
| Study group | Role | What they receive |
|---|---|---|
| AlloStim® | Experimental | 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 Receives: Biological: AlloStim® immunotherapy |
| Physician's Choice | Active comparator | Physician's Choice is sorafenib or levantinib or FOLFOX4 monotherapy Receives: Drug: FOLFOX regimen; Drug: Sorafenib; Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
the time from randomization till death
Measured: rom date of randomization until the date of death from any cause, assessed up to 48 months
Secondary outcomes (2)
Quality of Life Survey
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)
Measured: weekly assessments from baseline to 28 weeks
Time to Symptomatic Progression
To assess time to symptomatic progression (TTSP)
Measured: rom date of randomization weekly for up to 24 weeks until the date of first documented progression which ever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Aug 2023
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Why it stopped: Sponsor unable to fund
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mirror Biologics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Immunovative (Thailand) Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033522
- Sponsor's protocol ID
- MBI-003-LIVE
- Acronym
- ALIVE
- Status last verified
- Oct 2025
- First submitted
- 25 Aug 2021
- Last updated
- 23 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II/III Randomized, Controlled Clinical Study of AlloStim(R) vs Physician's Choice in Asian Subjects With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05033522
- Acronym / sponsor ID
- ALIVE / MBI-003-LIVE
- Conditions
- Hepatocellular Carcinoma
- Keywords
- liver cancer, immunotherapy, Thailand, Malaysia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Sponsor unable to fund
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mirror Biologics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Immunovative (Thailand) Co., Ltd
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| AlloStim® | Experimental | Biological: AlloStim® immunotherapyAlloStim® 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 | Active comparator | Drug: FOLFOX regimen, Drug: Sorafenib, Drug: LenvatinibPhysician's Choice is sorafenib or levantinib or FOLFOX4 monotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Males and females who are at least 18 years of age at time of enrollment
- Histologically or cytologically documented advanced HCC (BCLC stage C) disease at diagnosis.
- No prior treatment for BCLC class C disease.
- Child-Pugh Class A or subset of Child-Pugh Class B
- Performance status: ECOG < 2 with no deterioration over the previous 2 weeks
Key exclusion criteria (22 listed)
- Any prior cancer diagnosis (other than cured basal cell carcinoma, head and neck carcinoma in-situ, or superficial Ta, Tis, T1 bladder cancer) or concurrent cancer histologically different than HCC (e.g., cholangiocarcinoma).
- Child-Pugh liver function combined score >9 (Class C or Class D)
- Moderate uncontrolled or severe ascites (+3 on Child-Pugh calculator)
- Clinical symptoms of hepatic decompensation or presence of hepatic encephalopathy
- Severe stomach/esophageal varices requiring interventional treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlloStim® immunotherapy3 cycles of intradermal and intravenous administrations | Biological | AlloStim® |
| FOLFOX regimenAlso: Physician Choice FOLFOX4Comparative arm: Physician Choice of FOLFOX4 chemotherapy | Drug | Physician's Choice |
| SorafenibAlso: Sorafenib Physician's ChoiceComparative arm: Physician Choice of Sorafenib | Drug | Physician's Choice |
| LenvatinibAlso: Levantinib Physician's ChoiceComparative Arm: Physician's Choice of Levantinib | Drug | Physician's Choice |
Primary outcome
overall survival
Time frame: rom date of randomization until the date of death from any cause, assessed up to 48 months
the time from randomization till death
2 secondary outcomes
Quality of Life Survey
Time frame: weekly assessments from baseline to 28 weeks
Time to Symptomatic Progression
Time frame: rom date of randomization weekly for up to 24 weeks until the date of first documented progression which ever comes first
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing AlloStim® immunotherapy, FOLFOX regimen and Sorafenib in people with Hepatocellular Carcinoma, run by Mirror Biologics, Inc. at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Thailand, Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: rom date of randomization until the date of death from any cause, assessed up to 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2025.