NCT03008304

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 pancreatic-cancer

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

September 12, 2019

Status Verified

December 1, 2018

Enrollment Period

1 year

First QC Date

December 29, 2016

Last Update Submit

September 10, 2019

Conditions

Pancreatic Cancer

Keywords

Metastatic pancreatic cancerHigh-activity natural killer Immunotherapy

Outcome Measures

Primary Outcomes (1)

  • Relief degree of tumors

    It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）

    3 months

Secondary Outcomes (2)

  • Progress free survival（PFS）

    1 year

  • Overall survival（OS）

    3 year

Study Arms (2)

High-activity natural killer

EXPERIMENTAL

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

Control group

NO INTERVENTION

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).

Interventions

High-activity natural killerDRUG

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

Also known as: HANK cell
High-activity natural killer

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuda cancer institute of Fuda cancer hospital

Guangzhou, Guangdong, 510665, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2016

First Posted

January 2, 2017

Study Start

December 1, 2016

Primary Completion

December 1, 2017

Study Completion

September 1, 2019

Last Updated

September 12, 2019

Record last verified: 2018-12

Locations

CN(1)