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

March 13, 2017 updated by: Sinobioway Cell Therapy Co., Ltd.

Single Arm,Two Phase,Multicenter Trial to Evaluating the Efficacy and Safety of the CAR-T for Liver Cancer

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.

Study Overview

Status

Unknown

Conditions

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

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

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

Study Contact Backup

  • Name: mo chen, Investigator
  • Phone Number: 13605511023
  • Email: chemo@sohu.com

Study Locations

    • Anhui
      • Hefei, Anhui, China, 230000
        • Recruiting
        • Anhui No.2 Province People's Hospital

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

No older than 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
CAR - T back to lose 0 days to 180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Xianping Cheng, PI, associate chief physician

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)

November 14, 2015

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

March 23, 2016

First Submitted That Met QC Criteria

March 31, 2016

First Posted (Estimate)

April 6, 2016

Study Record Updates

Last Update Posted (Actual)

March 15, 2017

Last Update Submitted That Met QC Criteria

March 13, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • ACCO-2015-06-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plans to share data.

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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