Clinical trial NCT02725996: By Using Adoptive Transfer of Autologous NK Cells to Prevent Recurrence of Hepatocellular Carcinoma After Curative Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
Natural Killer cells
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2016-04-01
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence Free Survival(RFS) :RFS was measured from the date of randomization to the first recurrence or to death from any cause.
timeFrame: 3 years
measure: Overall Survival(OS) :Overall survival was measured from the date of randomization until death from any cause.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital of Third Millitary Medical University
state: Chongqing
Study officials:
affiliation: Biotherapy Center of Southwest Hospital
name: Cheng Qian, MD, PhD
role: STUDY_CHAIR
References: