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

NCT ID: NCT02399735

Last Updated: 2016-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2018-06-30

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.

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Low Dose NK cells ×4 times

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

Normal Dose NK cells ×4 times

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

Normal Dose NK cells ×8 times

Intervention Type: BIOLOGICAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Other Intervention Names

low dose Natural killer cells ×4 times; normal dose Natural killer cells ×4 times; normal dose Natural killer cells ×8 times

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Wang Guoying

Department of liver transplantation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yang Yang, MD

Role: STUDY_CHAIR

Third Affiliated Hospital, Sun Yat-Sen University

Locations

Wang Guoying

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wang Guoying, MD

Role: CONTACT

wanggy3@126.com

086-13632407313

Wang Guoying, MD

Role: CONTACT

Facility Contacts

Wang Guoying, MD

Role: primary

wanggy3@126.com

086-13632407313

Other Identifiers

(2014)2-126

Identifier Type: -

Identifier Source: org_study_id