Metastasis From Malignant Tumor of Kidney (Disorder), Reaction - Mixed Vaccine
Conditions
Brief summary
The aim of this study is the safety and efficacy of mix vaccine to small metastases of kidney cancer.
Detailed description
By enrolling patients with small metastases of kidney cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of mix vaccine. 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
BIOLOGICALMix vaccine
Each treatment: 0.5 ml /week, Subcutaneous injection of the deltoid muscle
Sponsors
Jinan University Guangzhou
Fuda Cancer Hospital, Guangzhou
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 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 \< 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relief degree of tumors | 3 months | It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progress free survival（PFS） | 1 year | The duration from the beginning of treatment to cancer recurrence or progression |
| Overall survival（OS） | 3 years | The duration from the beginning of treatment to patient death |
Countries
China
Outcome results
None listed