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Trial record 42 of 179 for:    DCLRE1C

ET 140202 -T Cell Combined With TAE or Sorafenib in the Treatment of Liver Cancer

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ClinicalTrials.gov Identifier: NCT03965546
Recruitment Status : Not yet recruiting
First Posted : May 29, 2019
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
Eureka Therapeutics Inc.
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

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.

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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
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arm Intervention/treatment
Experimental: ET140202-T cell combine with Sorafenib
Sorafenib treatment everyday and autologous ET140202-T cell administered by intravenous (IV) infusion
Combination Product: Sorafenib combined with ET140202-T cell
  1. 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

Experimental: ET140202-T cell combine with TAE
TAE treatment ahead every two times of autologous ET140202-T cell administered by intravenous (IV) infusion
Combination Product: TAE combined with ET140202-T cell
  1. Transarterial embolization(TAE) treatment
  2. Autologous T cells transduced with lentivirus encoding an anti-AFP (ET140202) expression construct -intravenous (i.v.)

Experimental: solo ET140202-T cell
autologous ET140202-T cell administered by intravenous (IV) infusion
Biological: ET140202-T cell
Autologous T cells transduced with lentivirus encoding an anti-AFP (ET140202) - expression construct -intravenous (i.v.)




Primary Outcome Measures :
  1. 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 :
  1. 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. 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).

  3. 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

  4. Median Survival(MS) [ Time Frame: at 4 months, 1 year, 2 years ]
    Median Survival(MS)at 4 months, 1 year and 2 years

  5. Overall survival(OS) [ Time Frame: at 2 years ]
    overall survival(OS)at 2 years

  6. AFP serum levels [ Time Frame: 2 years ]
    Percent change compared to the baseline

  7. 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

  8. Alpha-fetoprotein (AFP) expression in tumors [ Time Frame: 4-8 weeks ]
    Percent of AFP-positive cells in randomly selected fields in tumor biopsies.

  9. IL-6 serum levels [ Time Frame: 4-8 weeks ]
    Amount change compared to the baseline

  10. IL-2 serum levels [ Time Frame: 4-8 weeks ]
    Amount change compared to the baseline

  11. IL-10 serum levels [ Time Frame: 4-8 weeks ]
    Amount change compared to the baseline

  12. TNF-α serum levels [ Time Frame: 4-8 weeks ]
    Amount change compared to the baseline

  13. IFN-γ serum levels [ Time Frame: 4-8 weeks ]
    Amount change compared to the baseline



Information from the National Library of Medicine

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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
  • Adequate organ function as defined below:

    1. A pretreatment measured creatinine clearance (absolute value) of ≥50 ml/minute.
    2. Patients must have a serum direct bilirubin ≤3 x ULN, ALT and AST ≤5 x ULN.
    3. Ejection Fraction measured by echocardiogram or MUGA >50% (evaluation done within 6 weeks of screening does not need to be repeated)
    4. DLCO or FEV1 >45% predicted
    5. Absolute neutrophil count (ANC) ≥ 1500/mm3 (10^9/L), Platelet count ≥ 50,000/mm3 (10^9/L)
    6. INR ≤1.5 x ULN
    7. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965546


Contacts
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Contact: Yun Wang, PHD 86-18681869114 foolishyun@126.com

Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Eureka Therapeutics Inc.
Investigators
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Study Chair: Xue Hui, PHD First Affiliated Hospital of Xian Jiaotong University

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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT03965546     History of Changes
Other Study ID Numbers: 2019(ZD13)
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action