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

NCT ID: NCT02725996

Last Updated: 2017-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2019-04-30

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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curative therapy+NK infusion

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

Group Type EXPERIMENTAL

NK cells

Intervention Type BIOLOGICAL

Adjuvant adoptive immune therapy using NK cell 4 times

Curative therapy

Intervention Type OTHER

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

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

Group Type OTHER

Curative therapy

Intervention Type OTHER

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

Interventions

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NK cells

Adjuvant adoptive immune therapy using NK cell 4 times

Intervention Type BIOLOGICAL

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

Intervention Type OTHER

Other Intervention Names

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natural killer cell infusion

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southwest Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Zhi Yang

Researcher of Biotherapy Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cheng Qian, MD, PhD

Role: STUDY_CHAIR

Biotherapy Center of Southwest Hospital

Locations

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Southwest Hospital of Third Millitary Medical University

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

Central Contacts

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Cheng Qian, MD, PhD

Role: CONTACT

0086-023-68765461

Zhi Yang, MD, PhD

Role: CONTACT

0086-13206140093

Facility Contacts

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Cheng Qian, PhD

Role: primary

008615086883400

Zhi Yang, PhD

Role: backup

008613206140093

Other Identifiers

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TMMU-BTC-006

Identifier Type: -

Identifier Source: org_study_id

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