High-activity Natural Killer Immunotherapy for Small Metastases of Pancreatic Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Relief degree of tumors
Study Overview
Brief Summary
The aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of pancreatic cancer.
Detailed Description
By enrolling patients with small metastases of pancreatic cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of high-activity natural killer 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 < 2 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
Arms & Interventions
High-activity natural killer
In this group, the patients will receive multiple high-activity natural killer immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Intervention: High-activity natural killer (Drug)
Outcomes
Primary Outcomes
Relief degree of tumors
Time Frame: 3 months
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
Secondary Outcomes
- Progress free survival（PFS）(1 year)
- Overall survival（OS）(3 year)