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
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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UNKNOWN
PHASE2
140 participants
INTERVENTIONAL
2016-04-30
2019-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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curative therapy+NK infusion
Adjuvant adoptive immune therapy using NK cell 4 times after curative therapy
NK cells
Adjuvant adoptive immune therapy using NK cell 4 times
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
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
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
Interventions
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NK cells
Adjuvant adoptive immune therapy using NK cell 4 times
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Southwest Hospital, China
OTHER
Responsible Party
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Zhi Yang
Researcher of Biotherapy Center
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
Countries
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Central Contacts
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Facility Contacts
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Zhi Yang, PhD
Role: backup
Other Identifiers
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TMMU-BTC-006
Identifier Type: -
Identifier Source: org_study_id
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