By Using Adoptive Transfer of Autologous NK Cells to Prevent Recurrence of Hepatocellular Carcinoma After Curative Therapy

April 24, 2017 updated by: Zhi Yang, Southwest Hospital, China
To prove that the efficacy and safety of 'NK group' is superior to 'non-treatment group(Control group)' in patient undergone curative resection(RFA or operation) for hepatocellular carcinoma in China.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

No adjuvant therapy has been shown to extend the survival of patients with hepatocellular carcinoma receiving curative treatment.We investigated whether injections of NK cells prolongs recurrence-free survival of patients after curative therapy.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 2

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: Zhi Yang, MD, PhD
  • Phone Number: 0086-13206140093
  • Email: Lystch@qq.com

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • Southwest Hospital of Third Millitary Medical University

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 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Prior to the test, patient is fully explained about the purpose/ contents and characteristics of the testing medication, and the patient him(her)self, the guardian or the legal representative signed on written consent.
  2. Gender unlimited, age from 18 years to 70 years
  3. The patient is diagnosed as hepatocellular carcinoma by pathological/ radiological test and he (she) is in the stage of I or II. (refer to the attached file 10). Hepatocellular carcinoma should be shown by radiological test; on dynamic CT, dynamic MRI or on angiography.
  4. Child-Pugh Score should be less than 6
  5. No matter how the patient has been treated before, his (her) tumor should be totally removed by curative resection (RFA or operation). (based on the agreement date for written consent)
  6. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L).
  7. Patient's remaining life-time should be expected at least more than 3 months.

Exclusion Criteria:

  1. Hepatocellular carcinoma has been transferred by pathological/ radiological test (Stage III or Stage IV, refer to the exhibit 10)
  2. The carcinoma has been invaded to main portal vein or major branch hepatic vein
  3. Child-Pugh score is over 6
  4. Patient has serious problem with pulmonary function by sub- investigator's opinion
  5. Patient who has disease history of immune deficiency
  6. Diagnosed as an immune deficiency patient
  7. Patient who has disease history of malignant tumor within 5 years before this clinical trial.
  8. Patient who had anti-cancer medication before the clinical trial
  9. Patient has serious allergic-history by sub- investigator's opinion
  10. Patient has serious mental disease by sub- investigator's opinion
  11. Pregnant women, nursing mother or having intention of being pregnant during the clinical test
  12. Patient who participated in other clinical trial within 4 weeks before this clinical trial
  13. Patient who is incongruent to this clinical trial by sub- investigator's opinion.

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: curative therapy+NK infusion
Adjuvant adoptive immune therapy using NK cell 4 times after curative therapy
Biological: NK cells
Adjuvant adoptive immune therapy using NK cell 4 times
Other Names:
  • natural killer cell infusion
Other: Curative therapy
Patients who had undergone curative treatment(surgical resection or radiofrequency ablation for HCC of pretreatment clinical stage I or II were eligible for this study with no adjuvant treatment
OTHER: curative therapy
Patients who had undergone curative treatment(surgical resection or radiofrequency ablation[RFA]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
Other: Curative therapy
Patients who had undergone curative treatment(surgical resection or radiofrequency ablation for HCC of pretreatment clinical stage I or II were eligible for this study with no adjuvant treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence Free Survival(RFS) :RFS was measured from the date of randomization to the first recurrence or to death from any cause.
Time Frame: 3 years
3 years
Overall Survival(OS) :Overall survival was measured from the date of randomization until death from any cause.
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

Southwest Hospital, China

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

April 1, 2016

Primary Completion (ANTICIPATED)

April 1, 2018

Study Completion (ANTICIPATED)

April 1, 2019

Study Registration Dates

First Submitted

March 28, 2016

First Submitted That Met QC Criteria

March 31, 2016

First Posted (ESTIMATE)

April 1, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMMU-BTC-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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