High-activity Natural Killer Immunotherapy for Small Metastases of Colorectal Cancer

NCT ID: NCT03008499

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

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2019-09-01

Brief Summary

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

Detailed Description

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By enrolling patients with small metastases of colorectal 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).

Conditions

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Metastatic Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High-activity natural killer

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

Group Type EXPERIMENTAL

High-activity natural killer

Intervention Type BIOLOGICAL

Each treatment: 8\~10 billion cells in all, transfuion in 3 times, i.v.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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High-activity natural killer

Each treatment: 8\~10 billion cells in all, transfuion in 3 times, i.v.

Intervention Type BIOLOGICAL

Other Intervention Names

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HANK cell

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 \< 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 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

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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HANK-colorectal

Identifier Type: -

Identifier Source: org_study_id

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