Combination of Cryosurgery and NK Immunotherapy for Advanced Breast Cancer

Fuda Cancer Hospital, Guangzhou60 enrolled

Overview

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

By enrolling patients with breast 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 nature killer (NK) cells for advanced breast cancer. 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

Breast Cancer Recurrent

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: 70 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 in Fuda cancer hospital

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Relief degree

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

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

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.