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Study Evaluating the Efficacy and Safety With CAR-T for Liver Cancer (EECLC)

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ClinicalTrials.gov Identifier: NCT02729493
Recruitment Status : Recruiting
First Posted : April 6, 2016
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
Sinobioway Cell Therapy Co., Ltd.

Tracking Information
First Submitted Date  ICMJE March 23, 2016
First Posted Date  ICMJE April 6, 2016
Last Update Posted Date March 15, 2017
Actual Study Start Date  ICMJE November 14, 2015
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2016)
Disease control rates [ Time Frame: CAR - T back to lose 0 days to 180 days ]
Tumor complete remission number + partial response number + number of stable disease /Total number of cases being treated
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02729493 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating the Efficacy and Safety With CAR-T for Liver Cancer
Official Title  ICMJE Single Arm,Two Phase,Multicenter Trial to Evaluating the Efficacy and Safety of the CAR-T for Liver Cancer
Brief Summary This single-arm,multicenter Phase 2 trial will treat the patients who have relapsed or refractory liver cancer with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor(CAR)that will bind to tumour cells that express the EPCAM protein on the cell surface.The study will determine if these modified T cells help the body's immune system eliminate tumour cells.The trial will also study the safety of treatment with CAR-T,how long CAR-T cells stay in the patient's body and the impact of this treatment on survival.
Detailed Description This is a single-arm,multicenter Phase 2 study to evaluate the efficacy and safety of the CAR-T for Liver Cancer.The study will be conducted using a phaseⅠ /Ⅱ disign.The study will have the following sequential phases:Part A(screening leukapheresis,cell product preparation,and cytoreductive chemotherapy) and Part B(treatment and follow-up).The follow-up period for each paticipant is approximately 35 months after the final CAR-T infusion.The total duration of the study is expected to be approximately 3 years.A total of 25 patients may be enrolled over a period of 3 years.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Liver Neoplasms
Intervention  ICMJE Biological: EPCAM-targeted CAR-T cells
This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-EPCAM-modified T cells can recognize and kill tumor cells in the body,follow-up 35 months.
Study Arms  ICMJE Experimental: Single-arm
Name:The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form:injection Dosage:100ml/time Frequency:0 days,the first day,the second day,28days,29days Duration:total five times
Intervention: Biological: EPCAM-targeted CAR-T cells
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: March 31, 2016)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. According to UICC or liver cancer diagnosis and treatment guideline of diagnosis for hepatocellular carcinoma in patients with, the traditional treatment of invalid, advanced liver cancer, or postoperative relapse or refractory patients with hepatocellular carcinoma, and through flow cytometry or immune tissues (cell) chemistry, confirmation of tumor cells positive expression of relevant molecular targets;
  2. Age <=75 years old, both male and female;
  3. Is expected to survive more than 3 months;
  4. Physical condition is good: 0-2 score ECOG score;
  5. The lymphocyte count must > =0.4*10^9/L at the time of collection of peripheral blood;
  6. Vital organs (heart, kidney) function is normal, there is no major wound healing. No serious virus, bacterial infection;
  7. Non pregnancy and lactation;
  8. History of severe allergic reactions without biological products;
  9. Voluntary participation, good compliance,the subjects can cooperate with the experimental observation, and signed a written Informed Consent Form;
  10. At least one measurable lesion.

Exclusion Criteria:

  1. Pregnant or lactating women;
  2. Organ failure, such as heart: Class III and IV; liver: to Chlid grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness;
  3. Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation;
  4. Long term use of immunosuppressive drugs or people with severe autoimmune diseases;
  5. Any other chronic disease patients who have been treated with immune agents or hormone therapy;
  6. A serious infectious disease with severe, uncontrollable, wound healing
  7. Allergy to the interleukin and interferon cytokine;
  8. Coagulation abnormalities and severe thrombosis;
  9. Patients who have participated in other clinical trials or other clinical trials in the past 30 days
  10. The Investigator believe the patients should not participate in this experiment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xianping Cheng, PI 13805512522 chengxianping@sina.com
Contact: mo chen, Investigator 13605511023 chemo@sohu.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02729493
Other Study ID Numbers  ICMJE ACCO-2015-06-03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plans to share data.
Responsible Party Sinobioway Cell Therapy Co., Ltd.
Study Sponsor  ICMJE Sinobioway Cell Therapy Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xianping Cheng, PI associate chief physician
PRS Account Sinobioway Cell Therapy Co., Ltd.
Verification Date March 2017

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