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NCT02849015 Clinical Trial

Combination of Cryosurgery and NK Immunotherapy for Tumors in Transplanted Liver

Evidence of Liver Transplantation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02849015
Other study ID # NK-liverTx
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date July 1, 2016
Est. completion date July 1, 2018

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 natural killer(NK) immunotherapy to tumors in transplanted liver.

Description:

By enrolling patients with tumors in transplanted liver 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 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 20
Est. completion date July 1, 2018
Est. primary completion date July 1, 2017
Accepts healthy volunteers No
Gender All
Age group 30 Years to 60 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
Argon-helium cryosurgical system (percutaneous ablation under CT or ultrasound guidance)
Biological:
• NK immunotherapy
Natural killer cell(each treatment: about 10 billion cells transfusion in 3 times, i.v.)

Locations
Country Name City State
China 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 Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 3 months
Secondary Progress free survival(PFS) 1 year
Secondary Overall survival(OS) 3 years
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