High-activity Natural Killer Immunotherapy for Small Metastases of Non-small Cell Lung Cancer

Fuda Cancer Hospital, Guangzhou

Status and phase: Completed; Phase 2; Phase 1

Conditions: Non-small Cell Lung Cancer Metastatic

Treatments: Biological: high-activity natural killer

Study type: Interventional

Funder types: Other

Identifiers

NCT03007875

HANK-nsclc

Details and patient eligibility

About

The aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of non-small cell lung cancer.

Full description

By enrolling patients with small metastases of non-small cell lung cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of high-activity natural killer cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Enrollment: 20 patients

Sex: All

Ages: 30 to 60 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 < 2 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)

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20 participants in 2 patient groups

High-activity natural killer

Experimental group

Description:

In this group, the patients will receive multiple times of high-activity natural killer (HANK) immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Treatment:

Biological: high-activity natural killer

ControL

No Intervention group

Description:

In this group, the patients will receive no special treatment and as a control group. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).