High-activity Natural Killer Immunotherapy for Small Meta... | NCT03007836

Studies
High-activity Natural Killer Immunotherapy for Small Metastases of Nasopharyngeal Cancer

NCT03007836

Sponsor

Fuda Cancer Hospital, Guangzhou

Status

Completed

Last Update Posted

Sep 12, 2019Actual

Enrollment

20Actual

Phase

Phase 1Phase 2

Conditions

Metastatic Nasopharyngeal Cancer

Interventions

High-activity natural killer

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2016Actual

Primary Completion Date

Dec 1, 2017Actual

Completion Date

Jun 1, 2019Actual

First Submitted Date

Dec 30, 2016

First Submission Date that Met QC Criteria

Dec 30, 2016

First Posted Date

Jan 2, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2019

Last Update Posted Date

Sep 12, 2019Actual

Name	Class
Shenzhen Hank Bioengineering Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

By enrolling patients with small metastases of nasopharyngeal 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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High-activity natural killer	Experimental	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).	Biological: High-activity natural killer
Control	No Intervention	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).

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High-activity natural killer	Biological	Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v.	High-activity natural killer

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Progress free survival（PFS）		1 year
Overall survival（OS）		3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fuda cancer institute of Fuda cancer hospital		Guangzhou	Guangdong	510665	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009303	Nasopharyngeal Neoplasms

Ancestor Terms

ID	Term
D010610	Pharyngeal Neoplasms
D010039	Otorhinolaryngologic Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided