Recurrent Hepatocellular CarcinomaPhase 1/2NCT03634683
A Study of LioCyx in Patient With Recurrent HBV-related HCC Post Liver Transplantation
A Phase 1/2 study testing LioCyx in people with Recurrent Hepatocellular Carcinoma, run by Lion TCR Pte. Ltd. at 3 sites in 2 countries.
Trial summary
Hepatocellular carcinoma (HCC) represent approximately 70-85% of liver cancer, in which Hepatitis B virus (HBV) is the major etiologic agent accounting for at least 80% of HCC in Asian countries. Overall, transplantation remains the best option however, HCC recurrence rate is high among liver transplant patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Recurrent Hepatocellular Carcinoma
- What is being tested?
- LioCyx
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Aug 2018to Aug 2022
- Phase
- Phase 1/2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent locally advanced and/or metastatic hepatocellular carcinoma (HCC) post liver transplantation
- Life expectancy of 3 months or greater
- Have measurable disease by the revised response evaluation criteria in solid tumors (mRECIST)
- History of positive test for hepatitis B virus surface antigen (HBsAg)
- Expression of LioCyxTM target epitopes within specific human leukocyte antigen (HLA) class I profile
- Had received treatment with at least one standard therapy or refused, appropriate approved therapy for their disease
Show all 9Show fewer
- 21 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Willing and able to comply with all study procedures
Who cannot join
- Known, clinically suspected or has history of central nervous system (CNS) and bone metastasis
- Tumor burden in the liver exceeding 70%
- Significant ongoing immunologic rejection based on pathology and clinical diagnosis
- Evidence or history of significant bleeding diathesis or coagulopathy
- Prior exposure to any cell therapy such as, but not limited to NK, CIK, DC, CTL, stem cells therapy
- Known history of testing positive for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS)
- Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples
- Women who are pregnant or breast-feeding
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
China2 sites
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangzhou, 510000
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangzhou, 510080
About this study
Official title: A Phase I/II, Open Label, Single Arm, Multicenter Study of LioCyx in Subjects With Recurrent Hepatitis B Virus-Related Hepatocellular Carcinoma Post Liver Transplantation
Hepatocellular carcinoma (HCC) represent approximately 70-85% of liver cancer, in which Hepatitis B virus (HBV) is the major etiologic agent accounting for at least 80% of HCC in Asian countries. Overall, transplantation remains the best option however, HCC recurrence rate is high among liver transplant patients.
While there are limited treatment measures for HBV-related HCC recurrences, the study hypothesized that LioCyx is capable of lysing target liver cells expressing the HBV cognate antigens and provide clinical benefit to patients with HBV-related HCC.
Read the detailed description
The study is a Phase I/II, open label, single-arm, multicenter study of LioCyx. Subjects with recurrent hepatitis B virus-related hepatocellular carcinoma who undergone liver transplantation will be enrolled.
Approximately 6-12 subjects will be enrolled in Phase 1 dose regimen exploration, and approximately 60 subjects will be enrolled to characterize the safety and evaluate the efficacy of LioCyx"
All subjects will be followed up for survival until death.
- Conditions
- Recurrent Hepatocellular Carcinoma
- Being tested
- LioCyx
- Keywords
- recurrent hepatocellular carcinoma, hepatitis B virus-related, post liver transplantation, HCC
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LioCyxBiological
Autologous T cells transfected with mRNA encoding HBV antigen-specific TCR
| Study group | Role | What they receive |
|---|---|---|
| LioCyx | Experimental | This is a single-arm study.
Patients will receive escalating doses of LioCyx on Day 1, Day 8, Day 15 and Day 22 of the first 28-day treatment cycle, followed by every 2-week dosing on Day 1, Day 15, Day 29 and Day 43 of repeated cycle. A 21-day treatment break will be given between each cycle. Receives: Biological: LioCyx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety based on Incidence of Treatment-Emergent Adverse Events (AEs) and Serious AEs
Review the safety profile of LioCyx by assessing the incidence of AEs and SAEs
Measured: Start of Treatment until 28 days post last dose
Secondary outcomes (3)
Overall Response Rate
Tumor assessment will be according to mRECIST. This is based on percentage of participants with Complete Response (CR) and Partial Response (PR) according to mRECIST from baseline.
Measured: Start of Treatment until first documented CR or PR, assessed up to 62 treatment weeks (protocol-defined treatment duration is until disease progression, death, or loss to follow up, whichever came first)
Overall Survival according to mRECIST
Assess the efficacy following LioCyx in prolonging overall survival of patients in HBV-related HCC patients
Measured: Start of Treatment until first protocol-defined PD, and survival follow up until death, assessed up to 62 treatment weeks (protocol-defined treatment duration is until disease progression, death, or loss to follow up, whichever came first)
Quality of life of patients
Compare the quality of life of patients based on [Functional Assessment of Chronic Illness Therapy- Hepatobiliary (FACIT-Hep), version 4]
Measured: Baseline to 28 days post treatment (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study startAug 2018 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Why it stopped: Major changes in manufacturing process and investigational product
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lion TCR Pte. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634683
- Sponsor's protocol ID
- LTCR-HCC-001
- Status last verified
- Jun 2022
- First submitted
- 20 Jul 2018
- Last updated
- 30 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open Label, Single Arm, Multicenter Study of LioCyx in Subjects With Recurrent Hepatitis B Virus-Related Hepatocellular Carcinoma Post Liver Transplantation
- ClinicalTrials.gov ID
- NCT03634683
- Acronym / sponsor ID
- LTCR-HCC-001
- Conditions
- Recurrent Hepatocellular Carcinoma
- Keywords
- recurrent hepatocellular carcinoma, hepatitis B virus-related, post liver transplantation, HCC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Major changes in manufacturing process and investigational product
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lion TCR Pte. Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2018 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 16 Aug 2018 (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.
Hepatocellular carcinoma (HCC) represent approximately 70-85% of liver cancer, in which Hepatitis B virus (HBV) is the major etiologic agent accounting for at least 80% of HCC in Asian countries. Overall, transplantation remains the best option however, HCC recurrence rate is high among liver transplant patients.
While there are limited treatment measures for HBV-related HCC recurrences, the study hypothesized that LioCyx is capable of lysing target liver cells expressing the HBV cognate antigens and provide clinical benefit to patients with HBV-related HCC.
Detailed description
The study is a Phase I/II, open label, single-arm, multicenter study of LioCyx. Subjects with recurrent hepatitis B virus-related hepatocellular carcinoma who undergone liver transplantation will be enrolled.
Approximately 6-12 subjects will be enrolled in Phase 1 dose regimen exploration, and approximately 60 subjects will be enrolled to characterize the safety and evaluate the efficacy of LioCyx"
All subjects will be followed up for survival until death.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LioCyx | Experimental | Biological: LioCyxThis is a single-arm study. Patients will receive escalating doses of LioCyx on Day 1, Day 8, Day 15 and Day 22 of the first 28-day treatment cycle, followed by every 2-week dosing on Day 1, Day 15, Day 29 and Day 43 of repeated cycle. A 21-day treatment break will be given between each cycle. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Recurrent locally advanced and/or metastatic hepatocellular carcinoma (HCC) post liver transplantation
- Life expectancy of 3 months or greater
- Have measurable disease by the revised response evaluation criteria in solid tumors (mRECIST)
- History of positive test for hepatitis B virus surface antigen (HBsAg)
- Expression of LioCyxTM target epitopes within specific human leukocyte antigen (HLA) class I profile
Key exclusion criteria (8 listed)
- Known, clinically suspected or has history of central nervous system (CNS) and bone metastasis
- Tumor burden in the liver exceeding 70%
- Significant ongoing immunologic rejection based on pathology and clinical diagnosis
- Evidence or history of significant bleeding diathesis or coagulopathy
- Prior exposure to any cell therapy such as, but not limited to NK, CIK, DC, CTL, stem cells therapy
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 |
|---|---|---|
| LioCyxAutologous T cells transfected with mRNA encoding HBV antigen-specific TCR | Biological | LioCyx |
Primary outcome
Safety based on Incidence of Treatment-Emergent Adverse Events (AEs) and Serious AEs
Time frame: Start of Treatment until 28 days post last dose
Review the safety profile of LioCyx by assessing the incidence of AEs and SAEs
3 secondary outcomes
Overall Response Rate
Time frame: Start of Treatment until first documented CR or PR, assessed up to 62 treatment weeks (protocol-defined treatment duration is until disease progression, death, or loss to follow up, whichever came first)
Overall Survival according to mRECIST
Time frame: Start of Treatment until first protocol-defined PD, and survival follow up until death, assessed up to 62 treatment weeks (protocol-defined treatment duration is until disease progression, death, or loss to follow up, whichever came first)
Quality of life of patients
Time frame: Baseline to 28 days post treatment (end of treatment)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
Related trials for Recurrent Hepatocellular Carcinoma
Not yet recruitingPhase 2
NIVO+IPI Neoadjuvant Therapy for Recurrent Resectable HCC
Hepatocellular Carcinoma (HCC), Recurrent Hepatocellular Cancer
Active, not recruitingObservational study
Detect and Expunge Concealed Tumors of the Liver
Liver Cancer
Active, not recruitingPhase 3
Radiation Therapy With Protons or Photons in Treating Patients With Liver Cancer
Recurrent Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v7
RecruitingPhase 2
TACE or Ablation Combined With Sintilimab and Ipilimumab N01 as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With Intermediate-High Recurrence Risk
Hepato Cellular Carcinoma (HCC)
Not yet recruitingPhase 1/2
A Study of MDSY-1240, a STAT3 Degrader, for the Treatment of Hematologic Malignancies and Advanced Solid Tumors
Triple-Negative Breast Cancer (TNBC), Gastric Cancer (GC)
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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LioCyx in people with Recurrent Hepatocellular Carcinoma, run by Lion TCR Pte. Ltd. at 3 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 9 inclusion and 8 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: withdrawn, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China, Singapore. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Safety based on Incidence of Treatment-Emergent Adverse Events (AEs) and Serious AEs (time frame: Start of Treatment until 28 days post last dose). 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 30 Jun 2022.