Combination of Cryosurgery and NK Immunotherapy for Advanced Non-Small Cell Lung Cancer
Phase 1
Completed
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Registration Number
- NCT02843815
- Lead Sponsor
- Fuda Cancer Hospital, Guangzhou
- Brief Summary
The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to advanced NSCLC.
- Detailed Description
By enrolling patients with NSCLC 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 NSCLC.
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
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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 withgrade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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 Progress free survival（PFS） 1 year Overall survival（OS） 3 years
Trial Locations
- Locations (1)
Cancer Institute in Fuda cancer hospital
🇨🇳Guangzhou, Guangdong, China
Cancer Institute in Fuda cancer hospital🇨🇳Guangzhou, Guangdong, China