Solid Tumor
Conditions
Brief summary
This is a single center、single arm、open-label, to investigate the safety and efficacy of PD-1 and DC-CIK with anti-solid tumor
Interventions
DRUGpd-1 and dc-cik cells
Total dose of 10ml Keytruda will be administered at day0, 60million DC cells and 1.5 billion CIK at day1, 1.5 billion CIK cells at day2, 1.5 billion CIK cells at day3 .
Sponsors
The First People's Hospital of Yunnan Province/First People's Hospital of Yunan Provinve New Kunhua Hospital
Henan Provincial People's Hospital
Beijing Hospital
Allife Medical Science and Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Previously receiving ≥ first-line regimen chemotherapy; 2. Age over 3 years old and less than 14 years old; 3. The expected survival period is more than 3 months; 4. ECOG≤2; 5. Vital organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥ 50%, no obvious abnormality in ECG; blood oxygen saturation ≥ 90%; creatinine clearance calculated by Cockcroft-Gault formula ≥ 40ml/min; ALT and AST ≤ 3 times the normal range, total bilirubin ≤ 2.0 mg / dl; 6. Blood routine: Hgb≥80g/L, ANC≥1×109/L, PLT≥50×109/L; 7. There are measurable target lesions.
Exclusion criteria
1. Liver and kidney function: * Total bilirubin \> 2 x ULN (Gilbert syndrome \> 3 x ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 3 × ULN * Serum creatinine clearance \>60mL/min 2. Serological examination: * Absolute neutrophil count (ANC) \<0.75x109/L * Platelet count (PLT) \<50x109/L 3. Active hepatitis B (HBV-DNA \> 1000 copies / ml), hepatitis C, or uncontrolled infection; 4. The number of days of chemotherapy medication and the administration of hormones below 5mg is ≤3, and the number of days of withdrawal of hormones greater than 5mg is ≤5; 5. Active CNS disease (tumor cells in CSF); 6. Intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation; 7. creatinine \> 1.5 times the upper limit of normal or ALT / AST \> 3 times the upper limit of normal or bilirubin \> 2 times the upper limit of normal; 8. The New York Heart Association (NYHA) is classified as Level III or higher; 9. Uncontrolled diabetes; 10. With other uncontrolled diseases, the investigator believes that it is not suitable for joining; 11. Any situation that the investigator believes may increase the risk of the subject or interfere with the test results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| occurrence of treatment related adverse events | 1 year | occurrence of treatment related adverse events that are possible, likely. Or definitely related to study treatment. |
Outcome results
None listed