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

NCT ID: NCT02853903

Last Updated: 2019-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2019-07-01

Brief Summary

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

Detailed Description

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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).

Conditions

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Malignant Solid Tumour

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Allogenic NK immunotherapy

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).

Group Type EXPERIMENTAL

NK immunotherapy

Intervention Type BIOLOGICAL

Each treatment: 8-10 billion cells in all, transfusion in 3 times, i.v.

Autogenic NK immunotherapy

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).

Group Type ACTIVE_COMPARATOR

NK immunotherapy

Intervention Type BIOLOGICAL

Each treatment: 8-10 billion cells in all, transfusion in 3 times, i.v.

Interventions

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NK immunotherapy

Each treatment: 8-10 billion cells in all, transfusion in 3 times, i.v.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenzhen Hank Bioengineering Institute

OTHER

Sponsor Role collaborator

Fuda Cancer Hospital, Guangzhou

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jibing Chen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fuda Cancer Hospital, Guangzhou

Locations

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Fuda cancer institute of Fuda cancer hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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Auto-allo NK

Identifier Type: -

Identifier Source: org_study_id

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