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

Primary Purpose

Hepatocellular Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

NK cells

Curative therapy

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Natural Killer cells

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Gender unlimited, age from 18 years to 70 years
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.
Child-Pugh Score should be less than 6
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)
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).
Patient's remaining life-time should be expected at least more than 3 months.

Exclusion Criteria:

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

Sites / Locations

Southwest Hospital of Third Millitary Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

curative therapy+NK infusion

curative therapy

Arm Description

Adjuvant adoptive immune therapy using NK cell 4 times after 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

Outcomes

Primary Outcome Measures

Recurrence Free Survival(RFS) :RFS was measured from the date of randomization to the first recurrence or to death from any cause.

Overall Survival(OS) :Overall survival was measured from the date of randomization until death from any cause.

Secondary Outcome Measures

Full Information

NCT ID

NCT02725996

First Posted

March 28, 2016

Last Updated

April 24, 2017

Sponsor

Southwest Hospital, China

1. Study Identification

Unique Protocol Identification Number

NCT02725996

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Unknown status

Study Start Date

April 2016 (undefined)

Primary Completion Date

April 2018 (Anticipated)

Study Completion Date

April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Southwest Hospital, China

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma, Natural Killer cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

curative therapy+NK infusion

Arm Type

Experimental

Arm Description

Adjuvant adoptive immune therapy using NK cell 4 times after curative therapy

Arm Title

curative therapy

Arm Type

Other

Arm Description

Intervention Type

Biological

Intervention Name(s)

NK cells

Other Intervention Name(s)

natural killer cell infusion

Intervention Description

Adjuvant adoptive immune therapy using NK cell 4 times

Intervention Type

Other

Intervention Name(s)

Curative therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Title

Overall Survival(OS) :Overall survival was measured from the date of randomization until death from any cause.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Gender unlimited, age from 18 years to 70 years 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. Child-Pugh Score should be less than 6 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) 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). Patient's remaining life-time should be expected at least more than 3 months. Exclusion Criteria: Hepatocellular carcinoma has been transferred by pathological/ radiological test (Stage III or Stage IV, refer to the exhibit 10) The carcinoma has been invaded to main portal vein or major branch hepatic vein Child-Pugh score is over 6 Patient has serious problem with pulmonary function by sub- investigator's opinion Patient who has disease history of immune deficiency Diagnosed as an immune deficiency patient Patient who has disease history of malignant tumor within 5 years before this clinical trial. Patient who had anti-cancer medication before the clinical trial Patient has serious allergic-history by sub- investigator's opinion Patient has serious mental disease by sub- investigator's opinion Pregnant women, nursing mother or having intention of being pregnant during the clinical test Patient who participated in other clinical trial within 4 weeks before this clinical trial Patient who is incongruent to this clinical trial by sub- investigator's opinion.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cheng Qian, MD, PhD

Phone

0086-023-68765461

cqian3184@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhi Yang, MD, PhD

Phone

0086-13206140093

Lystch@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cheng Qian, MD, PhD

Organizational Affiliation

Biotherapy Center of Southwest Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Southwest Hospital of Third Millitary Medical University

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400000

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cheng Qian, PhD

Phone

008615086883400

cqian3184@163.com

First Name & Middle Initial & Last Name & Degree

Zhi Yang, PhD

Phone

008613206140093

First Name & Middle Initial & Last Name & Degree

Cheng Qian, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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