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出境医 / 临床实验 / ET 140202 -T Cell Combined With TAE or Sorafenib in the Treatment of Liver Cancer
ET 140202 -T Cell Combined With TAE or Sorafenib in the Treatment of Liver Cancer
Study Description
Brief 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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatocellular Carcinoma Liver Cancer Liver Neoplasms Metastatic Liver Cancer | Combination Product: Sorafenib combined with ET140202-T cell Combination Product: TAE combined with ET140202-T cell Biological: ET140202-T cell | Early Phase 1 |
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
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 27 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Clinical Study of ET 140202 -T Cell Combined With TAE or Sorafenib in the Treatment of Advanced Liver Cancer |
| Actual Study Start Date : | May 30, 2019 |
| Estimated Primary Completion Date : | June 2021 |
| Estimated Study Completion Date : | June 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
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Experimental: ET140202-T cell combine with Sorafenib
Sorafenib treatment everyday and autologous ET140202-T cell administered by intravenous (IV) infusion
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Combination Product: Sorafenib combined with ET140202-T cell
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Experimental: ET140202-T cell combine with TAE
TAE treatment ahead every two times of autologous ET140202-T cell administered by intravenous (IV) infusion
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Combination Product: TAE combined with ET140202-T cell
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Experimental: solo ET140202-T cell
autologous ET140202-T cell administered by intravenous (IV) infusion
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Biological: ET140202-T cell
Autologous T cells transduced with lentivirus encoding an anti-AFP (ET140202) - expression construct -intravenous (i.v.)
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Outcome Measures
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
- 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).
- 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
- Median Survival（MS） [ Time Frame: at 4 months, 1 year, 2 years ]Median Survival（MS）at 4 months, 1 year and 2 years
- Overall survival（OS） [ Time Frame: at 2 years ]overall survival（OS）at 2 years
- AFP serum levels [ Time Frame: 2 years ]Percent change compared to the baseline
- 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
- Alpha-fetoprotein (AFP) expression in tumors [ Time Frame: 4-8 weeks ]Percent of AFP-positive cells in randomly selected fields in tumor biopsies.
- IL-6 serum levels [ Time Frame: 4-8 weeks ]Amount change compared to the baseline
- IL-2 serum levels [ Time Frame: 4-8 weeks ]Amount change compared to the baseline
- IL-10 serum levels [ Time Frame: 4-8 weeks ]Amount change compared to the baseline
- TNF-α serum levels [ Time Frame: 4-8 weeks ]Amount change compared to the baseline
- IFN-γ serum levels [ Time Frame: 4-8 weeks ]Amount change compared to the baseline
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
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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.
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
Contacts and Locations
Contacts
| Contact: Yun Wang, PHD | 86-18681869114 | foolishyun@126.com |
Locations
| China, Shaanxi | |
| The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting |
| Xi'an, Shaanxi, China, 710061 | |
| Contact: Yun Wang 86-18681869114 foolishyun@126.com | |
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Eureka Therapeutics Inc.
Investigators
| Study Chair: | Xue Hui, PHD | First Affiliated Hospital of Xian Jiaotong University |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 24, 2019 | ||||
| First Posted Date ICMJE | May 29, 2019 | ||||
| Last Update Posted Date | August 8, 2019 | ||||
| Actual Study Start Date ICMJE | May 30, 2019 | ||||
| Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | ET 140202 -T Cell Combined With TAE or Sorafenib in the Treatment of Liver Cancer | ||||
| Official Title ICMJE | Clinical Study of ET 140202 -T Cell Combined With TAE or Sorafenib in the Treatment of Advanced Liver Cancer | ||||
| Brief 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 | ||||
| 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 ICMJE | Interventional | ||||
| Study Phase ICMJE | Early Phase 1 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
27 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | June 2022 | ||||
| Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03965546 | ||||
| Other Study ID Numbers ICMJE | 2019（ZD13） | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | First Affiliated Hospital Xi'an Jiaotong University | ||||
| Study Sponsor ICMJE | First Affiliated Hospital Xi'an Jiaotong University | ||||
| Collaborators ICMJE | Eureka Therapeutics Inc. | ||||
| Investigators ICMJE |
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| PRS Account | First Affiliated Hospital Xi'an Jiaotong University | ||||
| Verification Date | May 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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