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

A

Army Medical University

Status and phase

Unknown
Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

Other: Curative therapy
Biological: NK cells

Study type

Interventional

Funder types

Other

Identifiers

NCT02725996
TMMU-BTC-006

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

140 participants in 2 patient groups

curative therapy+NK infusion
Experimental group
Description:
Adjuvant adoptive immune therapy using NK cell 4 times after curative therapy
Treatment:
Other: Curative therapy
Biological: NK cells
curative therapy
Other group
Description:
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
Treatment:
Other: Curative therapy

Trial contacts and locations

1

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Central trial contact

Cheng Qian, MD, PhD; Zhi Yang, MD, PhD

Data sourced from clinicaltrials.gov

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