Combination of Cryosurgery and NK Immunotherapy for Advanced Breast Cancer

Phase 1

Completed

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

Detailed Description: 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).

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Cryosurgery and NK immunotherapy	NK immunotherapy	In this group, the patients will receive comprehensive cryosurgery first to destroy all big tumors, then receive multiple NK immunotherapy (intensive treatment: 6 times in first 3 months; then interval treatment: once every 3 months). The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets, circulating tumor cell).
Cryosurgery and NK immunotherapy	Cryosurgery	In this group, the patients will receive comprehensive cryosurgery first to destroy all big tumors, then receive multiple NK immunotherapy (intensive treatment: 6 times in first 3 months; then interval treatment: once every 3 months). The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets, circulating tumor cell).
Cryosurgery	Cryosurgery	In this group, the patients will receive comprehensive cryosurgery to destroy all big tumors. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets, circulating tumor cell).

Primary Outcome Measures

Name	Time	Method
Relief degree	3 months	It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）

Secondary Outcome Measures

Name	Time	Method
Overall survival（OS）	3 years
Progress free survival（PFS）	1 year

Locations (1): Cancer Institute in Fuda cancer hospital
🇨🇳
Guangzhou, Guangdong, China