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CompletedNCT03008330Updated Sep 12, 2019

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

A Phase 1/2 interventional study of High-activity natural killer in Tongue Cancer, sponsored by Fuda Cancer Hospital, Guangzhou. Completed at 1 site in China. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-09-12.

Sponsored by Fuda Cancer Hospital, Guangzhou · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
All
01

Study summary

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

Read the detailed description

By enrolling patients with small metastases of tongue 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).

02

Conditions studied

  • Tongue Cancer

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Keywords

  • Metastatic tongue cancer
  • High-activity natural killer
03

In context

Tongue Neoplasms

85 studies on the registry are indexed under Tongue Neoplasms; 13 are open to participants now.

This study's enrollment of 20 is below the median of 40 across 67 interventional studies indexed under Tongue Neoplasms.

Browse Tongue Neoplasms studies →

Lead sponsor

Fuda Cancer Hospital, Guangzhou is the lead sponsor of 113 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients with cardiac pacemaker
  • Patients with brain metastasis
  • Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    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).

    Biological: High-activity natural killer

  • No intervention
    Control

    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

  • BiologicalHigh-activity natural killer

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

06

What researchers measure

Primary outcomes

  1. Relief degree of tumors

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

    Time frame: 3 months

Secondary outcomes

  1. Progress free survival(PFS)

    Time frame: 1 year

  2. Overall survival(OS)

    Time frame: 3 years

07

Study locations

1 site
  • Fuda cancer institute of Fuda cancer hospital
    Guangzhou, Guangdong 510665, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03008330
Lead sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Shenzhen Hank Bioengineering Institute
Responsible party
Sponsor
First posted
Jan 2, 2017
Start date
Dec 1, 2016
Primary completion
Dec 1, 2017
Completion
Jun 1, 2019
Last update
Sep 12, 2019
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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