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Comparison of Autogenic and Allogenic NK Immunotherapy on the Outcome of Recurrent Solid Tumors

F

Fuda Cancer Hospital, Guangzhou

Status and phase

Completed
Phase 2

Conditions

Malignant Solid Tumour

Treatments

Biological: NK immunotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02853903
Auto-allo NK

Details and patient eligibility

About

The aim of this study is the efficacy of autogenic and allogenic natural killer (NK) immunotherapy on recurrent solid tumors.

Full description

By enrolling patients with multiple kinds of solid tumor adapted to enrolled criteria, this study will document for the first time the short/long term efficacy of auto/allogenic NK cells.The outcome will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Enrollment

20 patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
  • Body tumor 1-6, the maximum tumor length < 5 cm
  • KPS ≥ 70, lifespan > 6 months
  • Platelet count ≥ 80×109/L,white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion criteria

  • Patients with cardiac pacemaker
  • Patients with brain metastasis
  • Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Allogenic NK immunotherapy
Experimental group
Description:
In this group, the patients will receive more than 4 times of allogenic NK immunotherapies in 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Treatment:
Biological: NK immunotherapy
Autogenic NK immunotherapy
Active Comparator group
Description:
In this group, the patients will receive more than 4 times of autogenic NK immunotherapies in 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Treatment:
Biological: NK immunotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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