Safety Study of NK Cells From Sibship to Treat the Recurrence of HCC After Liver Transplantation

July 19, 2016 updated by: Wang Guoying, Third Affiliated Hospital, Sun Yat-Sen University

Safety Study of Nature Killer Cells From Sibship to Treat the Recurrence of Hepatocellular Carcinoma After Liver Transplantation

The purpose of this study is to explore the safety of NK cells from Sibship in patients with recurrent hepatocellular carcinoma after liver transplantation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Hepatocellular carcinoma (HCC) is one of the indications for the liver transplantation. With the advancement of liver transplantation associated science and technology, the recurrence of tumor posttransplantation has become the principal contradiction to worsen the prognosis and therefore the prevention of recurrence of HCC is the key to improve the efficacy of liver transplantation. Adoptive cellular immunotherapy has been applied in various malignant tumors including HCC and has obtained significant effects. But for patients with liver transplant in immunosuppressed states, to successfully apply the immune cells to prevent and treat HCC relapse after liver transplantation must balance immunosuppression and anti-tumor immunity. It is necessary to consider the safety of adoptive cellular immunotherapy,and it is also necessary to consider the effectiveness of treatment that the immune cells in the immunosuppression state can exert anti-tumor effects. Natural killer cells (NK cells) have MHC-unrestricted killing effect on malignant tumor cells and are not major mediating cells for GVHD, and might be an optimum choice to meet the above requirements.

Patients with confirmed recurrence of hepatocellular carcinoma after liver transplantation at the Third Affiliated Hospital of Sun Yat-sen University were enrolled.Participants in the study will be assigned to one of three treatment arms:

Arm A: Participants will received conventional treatment and low dose of NK cells treatment for 4 times. Arm B: Participants will received conventional treatment and normal dose of NK cells treatment for 4 times. Arm C: Participants will received conventional treatment and normal dose of NK cells treatment for 8 times. The cultured NK cells from the peripheral blood of the same blood type were taken and infused at intervals of two weeks. Periodic liver function recheck and imaging examination were conducted for 6 months after the last NK cells infusion.

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 1

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

  • Name: Wang Guoying, MD

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • Wang Guoying

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Proved hepatocellular carcinoma histologically after liver transplantation.
  • Confirmed recurrence of hepatocellular carcinoma by CT/MRI.
  • The same blood type relatives with blood transmitted diseases negative.
  • Written informed consent.

Exclusion Criteria:

  • Autoimmune diseases require long-term of glucocorticoid.
  • Other candidates who are judged to be not applicable to this study by investigators.
  • Poor compliance.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Received conventional treatment and NK cells once per two-week for the first two-month, at a dose of 5×10E9 NK cells.
Biological: Low Dose NK cells ×4 times
Received conventional treatment and NK cells once per two-week for the first two-month, at a dose of 5×10E9 NK cells.
Other Names:
  • low dose Natural killer cells ×4 times
Experimental: Arm B
Received conventional treatment and NK cells once per two-week for the first two-month, at a dose of 1×10E10 NK cells.
Biological: Normal Dose NK cells ×4 times
Received conventional treatment and NK cells once per two-week for the first two-month, at a dose of 1×10E10 NK cells.
Other Names:
  • normal dose Natural killer cells ×4 times
Experimental: Arm C
Received conventional treatment and NK cells once per two-week for the first four-month, at a dose of 1×10E10 NK cells.
Biological: Normal Dose NK cells ×8 times
Received conventional treatment and NK cells once per two-week for the first four-month, at a dose of 1×10E10 NK cells.
Other Names:
  • normal dose Natural killer cells ×8 times

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GVHD
Time Frame: 6 months
Rash, fever, diarrhea, jaundice etc. leukocyte, platelet, red blood cells reduce, abnormal liver function.Pathological biopsy if necessary.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute rejection
Time Frame: 6 months
abnormal liver function，pathological biopsy if necessary.
6 months

Collaborators and Investigators

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

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

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

October 1, 2014

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

March 23, 2015

First Submitted That Met QC Criteria

March 23, 2015

First Posted (Estimate)

March 26, 2015

Study Record Updates

Last Update Posted (Estimate)

July 21, 2016

Last Update Submitted That Met QC Criteria

July 19, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • (2014)2-126

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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