Combination of Irreversible Electroporation and NK Immunotherapy for Recurrent Liver Cancer

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03008343

Enrollment

Registered

2017-01-02

Start date

2016-12-01

Completion date

2019-07-01

Last updated

2019-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Liver Carcinoma

Keywords

Irreversible Electroporation, NK Immunotherapy, Recurrent Liver Carcinoma

Brief summary

The aim of this study is the safety and efficacy of irreversible electroporation (IRE) plus natural killer (NK) immunotherapy to recurrent liver cancer.

Detailed description

By enrolling patients with recurrent liver 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 IRE 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).

Interventions

DEVICEIrreversible Electroporation

One kind of electric ablation machine from Angiodynamic company (USA)

BIOLOGICALNatural killer

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Progress free survival（PFS）	1 year
Overall survival（OS）	3 year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026