Solid Tumor
Conditions
Brief summary
Combinations Natural Killer Cell (NK) With chemotherapy treatment may enhance the immune response and stop cancer cells from growing.
Detailed description
Patients in group A will receive 4 cycles of NK treatments within 8 months. Patients in group B will have no immunotherapy. Chemotherapy are available in both groups.The investigators want to evaluate the efficacy of combination of NK with chemotherapy in patients with treatment-refractory solid tumors
Interventions
COMBINATION_PRODUCTNK combined with Chemotherapy
Patients will receive 4 cycles of NK treatments combined with Chemotherapy within 8 months
DRUGChemotherapy
Patients will only receive Chemotherapy.
Sponsors
Yantai Yuhuangding Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with treatment-refractory advanced solid cancer can not accept operation; 2. Age 10 to 90 years; 3. Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points; 4. estimate survival \> 3 months; 5. Blood White Blood Cell(WBC)≥ 4×109/L, Hb ≥ 100g/L, Platelet Count (PLT)≥ 80×109/L; Alanine amino transferase (ALT) and aspartate amino transferase (AST)≤ 2 times of normal upper value; Serum Cr ≤ 2 normal upper value; 6. Without any other malignant disease; 7. With more than one scalable lesions; 8. Patients Voluntary attempt, and informed consent; 9. Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus.
Exclusion criteria
1. Patients who do not conform to the inclusion criteria; 2. Patients with uncontrolled infection; underlying disease that was severe or life-threatening (such as uncontrolled brain metastasis ); 3. Patients who were pregnant or lactating; 4. ECOG perform status ≥ 2;4. 5. Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rates (DCR) | 1 year | Disease Control Rates (Complete Remission + Partial Remission + Stable Disease), according to solid tumor response evaluation standard (response evaluation criteria in solid tumors, RECIST). |
Countries
China
Contacts
Primary ContactPeiwen Lian, PhD
Backup ContactJian Chen, PhD
Outcome results
None listed