Metastatic Esophageal Cancer
Conditions
Keywords
Esophageal Cancer, NK immunotherapy, Safety, Efficacy
Brief summary
The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to advanced esophageal cancer.
Detailed description
By enrolling patients with pancreatic 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 esophageal 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).
Interventions
DEVICECryosurgery
Argon-helium cryosurgical system
BIOLOGICALNK immunotherapy
Nutral killer cell immunotherapy for more than 6 times
Sponsors
Shenzhen Hank Bioengineering Institute
Fuda Cancer Hospital, Guangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
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 \< 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relief degree | 3 months | It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST） |
Secondary
| Measure | Time frame |
|---|---|
| Progress free survival（PFS） | 1 year |
| Overall survival（OS） | 3 years |
Countries
China
Outcome results
None listed