A Study of PD1 Combined With Dc-cik in the Treatment of Solid Tumors

Study Overview
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Brief Summary
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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

Official Title
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Clinical Study on the Safety and Efficacy of Pd-1 Combined With Dc-cik in the Treatment of Solid Tumors

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: pd-1 and dc-cik cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PD-1 and dc-cik treatment group<br> | Drug: pd-1 and dc-cik cells<br>* 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 .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of treatment related adverse events | occurrence of treatment related adverse events that are possible, likely. Or definitely related to study treatment. | 1 year |