Combination of Cryosurgery and NK Immunotherapy for Tumors in Transplanted Liver

Fuda Cancer Hospital, Guangzhou20 enrolled

Overview

The aim of this study is the safety and efficacy of cryosurgery plus natural killer(NK) immunotherapy to tumors in transplanted liver.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Liver Tumor Evidence of Liver Transplantation

Interventions

CryosurgeryDEVICE

Argon-helium cryosurgical system (percutaneous ablation under CT or ultrasound guidance)

NK immunotherapyBIOLOGICAL

Natural killer cell(each treatment: about 10 billion cells transfusion in 3 times, i.v.)

Eligibility

Sex: ALLMin age: 30 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Cancer Institute of Fuda cancer hospital

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time frame: 3 months

Secondary Outcomes

Progress free survival（PFS）

Time frame: 1 year

Overall survival（OS）

Time frame: 3 years

Data from ClinicalTrials.gov

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