NCT02399735

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at P25-P50 for phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Oct 2014

Typical duration for phase_1 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 21, 2016

Status Verified

June 1, 2016

Enrollment Period

3.7 years

First QC Date

March 23, 2015

Last Update Submit

July 19, 2016

Conditions

Hepatocellular Carcinoma

Keywords

NK cellsLiver TransplantationHepatocellular Carcinoma Recurrence

Outcome Measures

Primary Outcomes (1)

  • GVHD

    Rash, fever, diarrhea, jaundice etc. leukocyte, platelet, red blood cells reduce, abnormal liver function.Pathological biopsy if necessary.

    6 months

Secondary Outcomes (1)

  • Acute rejection

    6 months

Study Arms (3)

Arm A

EXPERIMENTAL

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

Arm B

EXPERIMENTAL

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

Arm C

EXPERIMENTAL

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

Interventions

Low Dose NK cells ×4 timesBIOLOGICAL

Received conventional treatment and NK cells once per two-week for the first two-month, at a dose of 5×10E9 NK cells.

Also known as: low dose Natural killer cells ×4 times
Arm A
Normal Dose NK cells ×4 timesBIOLOGICAL

Received conventional treatment and NK cells once per two-week for the first two-month, at a dose of 1×10E10 NK cells.

Also known as: normal dose Natural killer cells ×4 times
Arm B
Normal Dose NK cells ×8 timesBIOLOGICAL

Received conventional treatment and NK cells once per two-week for the first four-month, at a dose of 1×10E10 NK cells.

Also known as: normal dose Natural killer cells ×8 times
Arm C

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wang Guoying

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Yang Yang, MD

    Third Affiliated Hospital, Sun Yat-Sen University

    STUDY CHAIR

Central Study Contacts

Wang Guoying, MD

CONTACT

086-13632407313wanggy3@126.com

Wang Guoying, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of liver transplantation

Study Record Dates

First Submitted

March 23, 2015

First Posted

March 26, 2015

Study Start

October 1, 2014

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

July 21, 2016

Record last verified: 2016-06

Locations

CN(1)