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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02399735
• Other study ID #: (2014)2-126
• Status: Recruiting
• Phase: Phase 1
• First received: March 23, 2015
• Last updated: July 19, 2016
• Start date: October 2014
• Est. completion date: June 2018

Study information

• Verified date: June 2016
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Wang Guoying, MD
• Phone: 086-13632407313
• Email: wanggy3[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Recurrence

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Wang Guoying	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GVHD	Rash, fever, diarrhea, jaundice etc. leukocyte, platelet, red blood cells reduce, abnormal liver function.Pathological biopsy if necessary.	6 months	Yes
Secondary	Acute rejection	abnormal liver function,pathological biopsy if necessary.	6 months	Yes