Combination of Irreversible Electroporation and NK Immunotherapy for Recurrent Liver Cancer
Phase 1
Completed
- Conditions
- Recurrent Liver Carcinoma
- Interventions
- Device: Irreversible ElectroporationBiological: Natural killer
- Registration Number
- NCT03008343
- Lead Sponsor
- Fuda Cancer Hospital, Guangzhou
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Electroporation Irreversible Electroporation In this group, the patients will receive regular irreversible electroporation (IRE) treatment to control the tumor growth. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). Electroporation and natural killer Natural killer In this group, the patients will receive regular irreversible electroporation (IRE) treatment in combination with multiple natural killer (NK) immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). Electroporation and natural killer Irreversible Electroporation In this group, the patients will receive regular irreversible electroporation (IRE) treatment in combination with multiple natural killer (NK) immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
- Primary Outcome Measures
Name Time Method Relief degree of tumors 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 year
Trial Locations
- Locations (1)
Fuda cancer institute of Fuda cancer hospital
🇨🇳Guangzhou, Guangdong, China