Hepatocellular CarcinomaEarly Phase 1NCT03965546
ET 140202 -T Cell Combined With TAE or Sorafenib in the Treatment of Liver Cancer
A Early Phase 1 study testing Sorafenib combined with ET140202-T cell, TAE combined with ET140202-T cell and ET140202-T cell in people with Hepatocellular Carcinoma and Liver Cancer, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of ET 140202 -T cell combined With TAE or Sorafenib in the treatment of liver cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cancer, Liver Neoplasms
- What is being tested?
- Sorafenib combined with ET140202-T cell, TAE combined with ET140202-T cell and ET140202-T cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2019to Jun 2022
- Phase
- Early Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AFP-expressing HCC and serum AFP >10 x ULN
- Abandon or failure in first or second line treatment
- Molecular HLA class I typing confirms participant carries at least one HLA-A02 allele
- Child-Pugh score of A or B, ECOG 0-2, Life expectancy > 6 months
- Measurable disease as defined by: at least 1 liver lesion that can be accurately and serially measured.
- Negative serum pregnancy test for women with childbearing potential
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- Adequate organ function as defined below:
- A pretreatment measured creatinine clearance (absolute value) of ≥50 ml/minute.
- Patients must have a serum direct bilirubin ≤3 x ULN, ALT and AST ≤5 x ULN.
- Ejection Fraction measured by echocardiogram or MUGA >50% (evaluation done within 6 weeks of screening does not need to be repeated)
- DLCO or FEV1 >45% predicted
- Absolute neutrophil count (ANC) ≥ 1500/mm3 (10^9/L), Platelet count ≥ 50,000/mm3 (10^9/L)
- INR ≤1.5 x ULN
- Informed Consent/Assent: All subjects must have the ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Patients with decompensated cirrhosis: Child-Pugh Score C
- Patients with tumor infiltration in the portal vein, hepatic veins or inferior vena cava that completely blocks circulation in liver.
- Patients with an organ transplantation history
- Patients with dependence on corticosteroids
- Patients with active autoimmune diseases requiring systemic immunosuppressive therapy
- Patients who are currently receiving or received within past 30 days anti-cancer therapy, local treatments for liver tumors (radiotherapy, embolism, ablation) or liver surgery
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- Patients currently receiving other investigational treatments (biotherapy, chemotherapy, or radiotherapy)
- Participants with other active malignancies (except non-melanoma skin cancer and cervical cancer) within two years. Patients with a history of successfully-treated tumors with no sign of recurrence in the last two years may be enrolled.
- Patients with other uncontrolled diseases, such as active infections Acute or chronic active hepatitis B or hepatitis C.
- Women who are pregnant or breast-feed
- HIV-infection
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Yun Wang, 86-18681869114, foolishyun@126.com
About this study
Official title: Clinical Study of ET 140202 -T Cell Combined With TAE or Sorafenib in the Treatment of Advanced Liver Cancer
The purpose of this study is to evaluate the efficacy and safety of ET 140202 -T cell combined With TAE or Sorafenib in the treatment of liver cancer
Read the detailed description
The molecular target for ET140202-T cells is HLA-A02 complexed with a HLA-A02-restricted peptide of alpha fetoprotein (AFP), which is expressed on 60-80 percent of hepatocellular carcinoma (HCC). This clinical study evaluates the safety and pharmacokinetics of ET140202-T cells with TAE or Sorafenib in patients with HCC who have no available curative therapeutic options and a poor overall prognosis.
- Being tested
- Sorafenib combined with ET140202-T cell, TAE combined with ET140202-T cell, ET140202-T cell
- 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.
Sorafenib combined with ET140202-T cellCombination product
- Sorafenib starting dose of 400mg b.i.d. a.c.
- Autologous T cells transduced with lentivirus encoding an anti-AFP (ET140202) expression construct by intravenous (IV) infusion
TAE combined with ET140202-T cellCombination product
- Transarterial embolization(TAE) treatment
- Autologous T cells transduced with lentivirus encoding an anti-AFP (ET140202) expression construct -intravenous (i.v.)
ET140202-T cellBiological
Autologous T cells transduced with lentivirus encoding an anti-AFP (ET140202) - expression construct -intravenous (i.v.)
| Study group | Role | What they receive |
|---|---|---|
| ET140202-T cell combine with Sorafenib | Experimental | Sorafenib treatment everyday and autologous ET140202-T cell administered by intravenous (IV) infusion Receives: Combination Product: Sorafenib combined with ET140202-T cell |
| ET140202-T cell combine with TAE | Experimental | TAE treatment ahead every two times of autologous ET140202-T cell administered by intravenous (IV) infusion Receives: Combination Product: TAE combined with ET140202-T cell |
| solo ET140202-T cell | Experimental | autologous ET140202-T cell administered by intravenous (IV) infusion Receives: Biological: ET140202-T cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of ARTEMIS T cell treatment-related adverse events
Include but not limited to: Fever, chills, nausea, vomiting, jaundice and other gastrointestinal symptoms; Fatigue, hypotension, respiratory distress; Tumor lysis syndrome; Cytokine release syndrome; Neutropenia, thrombocytopenia; Liver and kidney dysfunction. Assessed at all visits.
Measured: 28 days up to 2 years
Secondary outcomes (13)
Rate of disease response by RECIST in the liver
Response rates will be estimated as the percent of patients with objective response (OR)，which was defined as any of complete remission (CR), partial response (PR) at 2 years.
Measured: 2 years
Rate of disease response by RECIST at non-liver sites
Response rates will be estimated as the percent of patients with objective response (OR), complete remission (CR), partial response (PR), stable disease (SD), no response (NR), overall survival (OS).
Measured: 2 years
Progression free survival (PFS)
Progression free survival (PFS) at 4 months, 1 year and 2 years
Measured: at 4 months, 1 year, 2 years
Median Survival（MS）
Median Survival（MS）at 4 months, 1 year and 2 years
Measured: at 4 months, 1 year, 2 years
Overall survival（OS）
overall survival（OS）at 2 years
Measured: at 2 years
AFP serum levels
Percent change compared to the baseline
Measured: 2 years
Number of ET140202-T cells in peripheral blood
Number of ET140202-T cells in peripheral blood will be presented as Time to peak, Time to baseline level
Measured: 2 years
Alpha-fetoprotein (AFP) expression in tumors
Percent of AFP-positive cells in randomly selected fields in tumor biopsies.
Measured: 4-8 weeks
IL-6 serum levels
Amount change compared to the baseline
Measured: 4-8 weeks
IL-2 serum levels
Amount change compared to the baseline
Measured: 4-8 weeks
IL-10 serum levels
Amount change compared to the baseline
Measured: 4-8 weeks
TNF-α serum levels
Amount change compared to the baseline
Measured: 4-8 weeks
IFN-γ serum levels
Amount change compared to the baseline
Measured: 4-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start30 May 2019
- Primary completionJun 2021 (estimated)
- Study completionJun 2022 (estimated)
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.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Eureka Therapeutics Inc.
- Responsible party
- Sponsor
- Investigators
- Xue Hui, PHD, Study chair, First Affiliated Hospital of Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965546
- Sponsor's protocol ID
- 2019（ZD13）
- Status last verified
- May 2019
- First submitted
- 24 May 2019
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of ET 140202 -T Cell Combined With TAE or Sorafenib in the Treatment of Advanced Liver Cancer
- ClinicalTrials.gov ID
- NCT03965546
- Acronym / sponsor ID
- 2019（ZD13）
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Eureka Therapeutics Inc.
- Study start
- 30 May 2019 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 29 May 2019 (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.
The purpose of this study is to evaluate the efficacy and safety of ET 140202 -T cell combined With TAE or Sorafenib in the treatment of liver cancer
Detailed description
The molecular target for ET140202-T cells is HLA-A02 complexed with a HLA-A02-restricted peptide of alpha fetoprotein (AFP), which is expressed on 60-80 percent of hepatocellular carcinoma (HCC). This clinical study evaluates the safety and pharmacokinetics of ET140202-T cells with TAE or Sorafenib in patients with HCC who have no available curative therapeutic options and a poor overall prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ET140202-T cell combine with Sorafenib | Experimental | Combination Product: Sorafenib combined with ET140202-T cellSorafenib treatment everyday and autologous ET140202-T cell administered by intravenous (IV) infusion |
| ET140202-T cell combine with TAE | Experimental | Combination Product: TAE combined with ET140202-T cellTAE treatment ahead every two times of autologous ET140202-T cell administered by intravenous (IV) infusion |
| solo ET140202-T cell | Experimental | Biological: ET140202-T cellautologous ET140202-T cell administered by intravenous (IV) infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- AFP-expressing HCC and serum AFP >10 x ULN
- Abandon or failure in first or second line treatment
- Molecular HLA class I typing confirms participant carries at least one HLA-A02 allele
- Child-Pugh score of A or B, ECOG 0-2, Life expectancy > 6 months
- Measurable disease as defined by: at least 1 liver lesion that can be accurately and serially measured.
Key exclusion criteria (11 listed)
- Patients with decompensated cirrhosis: Child-Pugh Score C
- Patients with tumor infiltration in the portal vein, hepatic veins or inferior vena cava that completely blocks circulation in liver.
- Patients with an organ transplantation history
- Patients with dependence on corticosteroids
- Patients with active autoimmune diseases requiring systemic immunosuppressive 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 |
|---|---|---|
| Sorafenib combined with ET140202-T cell1. Sorafenib starting dose of 400mg b.i.d. a.c. 2. Autologous T cells transduced with lentivirus encoding an anti-AFP (ET140202) expression construct by intravenous (IV) infusion | Combination product | ET140202-T cell combine with Sorafenib |
| TAE combined with ET140202-T cell1. Transarterial embolization(TAE) treatment 2. Autologous T cells transduced with lentivirus encoding an anti-AFP (ET140202) expression construct -intravenous (i.v.) | Combination product | ET140202-T cell combine with TAE |
| ET140202-T cellAutologous T cells transduced with lentivirus encoding an anti-AFP (ET140202) - expression construct -intravenous (i.v.) | Biological | solo ET140202-T cell |
Primary outcome
Frequency of ARTEMIS T cell treatment-related adverse events
Time frame: 28 days up to 2 years
Include but not limited to: Fever, chills, nausea, vomiting, jaundice and other gastrointestinal symptoms; Fatigue, hypotension, respiratory distress; Tumor lysis syndrome; Cytokine release syndrome; Neutropenia, thrombocytopenia; Liver and kidney dysfunction. Assessed at all visits.
13 secondary outcomes
Rate of disease response by RECIST in the liver
Time frame: 2 years
Rate of disease response by RECIST at non-liver sites
Time frame: 2 years
Progression free survival (PFS)
Time frame: at 4 months, 1 year, 2 years
Median Survival（MS）
Time frame: at 4 months, 1 year, 2 years
Overall survival（OS）
Time frame: at 2 years
AFP serum levels
Time frame: 2 years
Number of ET140202-T cells in peripheral blood
Time frame: 2 years
Alpha-fetoprotein (AFP) expression in tumors
Time frame: 4-8 weeks
IL-6 serum levels
Time frame: 4-8 weeks
IL-2 serum levels
Time frame: 4-8 weeks
IL-10 serum levels
Time frame: 4-8 weeks
TNF-α serum levels
Time frame: 4-8 weeks
IFN-γ serum levels
Time frame: 4-8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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.
Xue Hui, PHD study chair
First Affiliated Hospital of Xian Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sorafenib combined with ET140202-T cell, TAE combined with ET140202-T cell and ET140202-T cell in people with Hepatocellular Carcinoma and Liver Cancer, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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 14 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Contact Yun Wang, PHD (86-18681869114, foolishyun@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of ARTEMIS T cell treatment-related adverse events (time frame: 28 days up to 2 years). 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 8 Aug 2019.