High-activity Natural Killer Immunotherapy For Small Metastases Of Pancreatic Cancer

Study Overview

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

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

By enrolling patients with small metastases of pancreatic 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).

Pancreatic Cancer

DRUG: High-activity natural killer

HANK-pancreas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-12-29	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-09-10
First Submitted that Met QC Criteria 2016-12-30	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-09-12
First Posted (ACTUAL) 2017-01-02	Results First Posted N/A	Last Verified 2018-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: High-activity natural killer In this group, the patients will receive multiple high-activity natural killer immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).	DRUG: High-activity natural killer Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v.
NO_INTERVENTION: Control group 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).

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: High-activity natural killer

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

DRUG: High-activity natural killer

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

NO_INTERVENTION: Control group

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).

Primary Outcome Measures	Measure Description	Time Frame
Relief degree of tumors	It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）	3 months

Secondary Outcome Measures	Measure Description	Time Frame
Progress free survival（PFS）		1 year
Overall survival（OS）		3 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
30 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Shenzhen Hank Bioengineering Institute

Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record