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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02849379
Other study ID # NK-tongue
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date July 1, 2016
Est. completion date July 1, 2019

Study information

Verified date July 2018
Source Fuda Cancer Hospital, Guangzhou
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to recurrent tongue cancer.


Description:

By enrolling patients with recurrent tongue cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and natural killer (NK) 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).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 1, 2019
Est. primary completion date July 1, 2017
Accepts healthy volunteers No
Gender All
Age group 30 Years to 70 Years
Eligibility 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 < 5 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Cryosurgery
Percutaneous ablation under CT or ultrasound guidance
Biological:
NK immunotherapy
Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v.

Locations

Country Name City State
China Fuda cancer institute of Fuda cancer hospital Guangzhou Guangdong

Sponsors (2)

Lead Sponsor Collaborator
Fuda Cancer Hospital, Guangzhou Shenzhen Hank Bioengineering Institute

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relief degree of tumors It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST) 3 months
Secondary Progress free survival(PFS) 1 year
Secondary Overall survival(OS) 3 years