- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03965546
ET 140202 -T Cell Combined With TAE or Sorafenib in the Treatment of Liver Cancer
August 6, 2019 updated by: First Affiliated Hospital Xi'an Jiaotong University
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
Study Overview
Status
Unknown
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 Type
Interventional
Enrollment (Anticipated)
27
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yun Wang, PHD
- Phone Number: 86-18681869114
- Email: foolishyun@126.com
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710061
- Recruiting
- The First Affiliated Hospital of Xi'an Jiaotong University
-
Contact:
- Yun Wang
- Phone Number: 86-18681869114
- Email: foolishyun@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
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.
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: ET140202-T cell combine with Sorafenib
Sorafenib treatment everyday and autologous ET140202-T cell administered by intravenous (IV) infusion
|
|
EXPERIMENTAL: ET140202-T cell combine with TAE
TAE treatment ahead every two times of autologous ET140202-T cell administered by intravenous (IV) infusion
|
|
EXPERIMENTAL: solo ET140202-T cell
autologous ET140202-T cell administered by intravenous (IV) infusion
|
Autologous T cells transduced with lentivirus encoding an anti-AFP (ET140202) - expression construct -intravenous (i.v.)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
28 days up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of disease response by RECIST at non-liver sites
Time Frame: 2 years
|
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).
|
2 years
|
AFP serum levels
Time Frame: 2 years
|
Percent change compared to the baseline
|
2 years
|
Rate of disease response by RECIST in the liver
Time Frame: 2 years
|
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.
|
2 years
|
Progression free survival (PFS)
Time Frame: at 4 months, 1 year, 2 years
|
Progression free survival (PFS) at 4 months, 1 year and 2 years
|
at 4 months, 1 year, 2 years
|
Median Survival(MS)
Time Frame: at 4 months, 1 year, 2 years
|
Median Survival(MS)at 4 months, 1 year and 2 years
|
at 4 months, 1 year, 2 years
|
Overall survival(OS)
Time Frame: at 2 years
|
overall survival(OS)at 2 years
|
at 2 years
|
Number of ET140202-T cells in peripheral blood
Time Frame: 2 years
|
Number of ET140202-T cells in peripheral blood will be presented as Time to peak, Time to baseline level
|
2 years
|
Alpha-fetoprotein (AFP) expression in tumors
Time Frame: 4-8 weeks
|
Percent of AFP-positive cells in randomly selected fields in tumor biopsies.
|
4-8 weeks
|
IL-6 serum levels
Time Frame: 4-8 weeks
|
Amount change compared to the baseline
|
4-8 weeks
|
IL-2 serum levels
Time Frame: 4-8 weeks
|
Amount change compared to the baseline
|
4-8 weeks
|
IL-10 serum levels
Time Frame: 4-8 weeks
|
Amount change compared to the baseline
|
4-8 weeks
|
TNF-α serum levels
Time Frame: 4-8 weeks
|
Amount change compared to the baseline
|
4-8 weeks
|
IFN-γ serum levels
Time Frame: 4-8 weeks
|
Amount change compared to the baseline
|
4-8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Xue Hui, PHD, First Affiliated Hospital of Xian Jiaotong University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 30, 2019
Primary Completion (ANTICIPATED)
June 1, 2021
Study Completion (ANTICIPATED)
June 1, 2022
Study Registration Dates
First Submitted
May 24, 2019
First Submitted That Met QC Criteria
May 24, 2019
First Posted (ACTUAL)
May 29, 2019
Study Record Updates
Last Update Posted (ACTUAL)
August 8, 2019
Last Update Submitted That Met QC Criteria
August 6, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019(ZD13)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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