Status:
UNKNOWN
A Study of PD1 Combined With Dc-cik in the Treatment of Solid Tumors
Lead Sponsor:
Allife Medical Science and Technology Co., Ltd.
Collaborating Sponsors:
The First People's Hospital of Yunnan Province/First People's Hospital of Yunan Provinve New Kunhua Hospital
Henan Provincial People's Hospital
Conditions:
Solid Tumor
Eligibility:
All Genders
18-60 years
Phase:
EARLY_PHASE1
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
Eligibility Criteria
Inclusion
- Previously receiving ≥ first-line regimen chemotherapy;
- Age over 3 years old and less than 14 years old;
- The expected survival period is more than 3 months;
- ECOG≤2;
- 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;
- Blood routine: Hgb≥80g/L, ANC≥1×109/L, PLT≥50×109/L;
- There are measurable target lesions.
Exclusion
- 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
- Serological examination:
- Absolute neutrophil count (ANC) \<0.75x109/L
- Platelet count (PLT) \<50x109/L
- Active hepatitis B (HBV-DNA \> 1000 copies / ml), hepatitis C, or uncontrolled infection;
- 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;
- Active CNS disease (tumor cells in CSF);
- Intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation;
- 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;
- The New York Heart Association (NYHA) is classified as Level III or higher;
- Uncontrolled diabetes;
- With other uncontrolled diseases, the investigator believes that it is not suitable for joining;
- Any situation that the investigator believes may increase the risk of the subject or interfere with the test results.
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03815630
Start Date
February 1 2019
End Date
February 1 2021
Last Update
January 30 2019
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