Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 42 of 181 for:    DCLRE1C

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03965546
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : August 8, 2019
Sponsor:
Collaborator:
Eureka Therapeutics Inc.
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an 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
 (submitted: May 24, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03965546 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
  • 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
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
Condition  ICMJE
  • Hepatocellular Carcinoma
  • Liver Cancer
  • Liver Neoplasms
  • Metastatic Liver Cancer
Intervention  ICMJE
  • 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
  • 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.)
  • Biological: ET140202-T cell
    Autologous T cells transduced with lentivirus encoding an anti-AFP (ET140202) - expression construct -intravenous (i.v.)
Study Arms  ICMJE
  • Experimental: ET140202-T cell combine with Sorafenib
    Sorafenib treatment everyday and autologous ET140202-T cell administered by intravenous (IV) infusion
    Intervention: Combination Product: Sorafenib combined with ET140202-T cell
  • Experimental: ET140202-T cell combine with TAE
    TAE treatment ahead every two times of autologous ET140202-T cell administered by intravenous (IV) infusion
    Intervention: Combination Product: TAE combined with ET140202-T cell
  • Experimental: solo ET140202-T cell
    autologous ET140202-T cell administered by intravenous (IV) infusion
    Intervention: Biological: ET140202-T cell
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 24, 2019)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yun Wang, PHD 86-18681869114 foolishyun@126.com
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
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
Study Chair: Xue Hui, PHD First Affiliated Hospital of Xian Jiaotong University
PRS Account First Affiliated Hospital Xi'an Jiaotong University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP