By Using Adoptive Transfer of Autologous NK Cells to Prevent Recurrence of Hepatocellular Carcinoma After Curative Therapy
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hepatocellular-carcinoma
Started Apr 2016
Typical duration for phase_2 hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2016
CompletedFirst Posted
Study publicly available on registry
April 1, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedApril 25, 2017
March 1, 2016
2 years
March 28, 2016
April 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Recurrence Free Survival(RFS) :RFS was measured from the date of randomization to the first recurrence or to death from any cause.
3 years
Overall Survival(OS) :Overall survival was measured from the date of randomization until death from any cause.
3 years
Study Arms (2)
curative therapy+NK infusion
EXPERIMENTALAdjuvant adoptive immune therapy using NK cell 4 times after curative therapy
curative therapy
OTHERPatients 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
Interventions
Adjuvant adoptive immune therapy using NK cell 4 times
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southwest Hospital of Third Millitary Medical University
Chongqing, Chongqing Municipality, 400000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Cheng Qian, MD, PhD
Biotherapy Center of Southwest Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher of Biotherapy Center
Study Record Dates
First Submitted
March 28, 2016
First Posted
April 1, 2016
Study Start
April 1, 2016
Primary Completion
April 1, 2018
Study Completion
April 1, 2019
Last Updated
April 25, 2017
Record last verified: 2016-03