Super DC cell injections to prevent tumor recurrence after surgery.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, controlled Phase 1/2 exploratory trial testing perioperative injections of a Super dendritic cell (Super DC) vaccine in patients who have undergone radical resection of malignant solid tumors. Eligible adults (18–80 years) with no evidence of disease on imaging and ECOG 0–1 will have peripheral blood mononuclear cells collected and receive one or more Super DC injections, with safety and recurrence monitored over time. A safety verification stage requires tumor immunohistochemistry positive for Survivin, P53, or MUC1, and patients will be followed with serial imaging and clinical assessments to compare recurrence rates to a control arm receiving standard follow-up. The trial is sponsored by Shanghai Cell Therapy Group and conducted at Shanghai Mengchao Tumor Hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18-80 years old, weight ≥ 40kg; No gender limit；
* Subjects with malignant solid tumors diagnosed by histology or cytology and undergoing radical resection surger；
* At the beginning of the study (after surgery), there were no lesions, no local recurrence or distant metastasis on the imaging, and no brain metastasis (images within one month before enrollment can be used for screening)；
* Subjects in the safety verification stage need to provide immunohistochemical test results with positive expression of Survivin or P53 or MUC1;
* ECOG score 0-1 points;
* There are sufficient venous channels and no contraindications for peripheral blood mononuclear cell collection surgery;
* Organs and bone marrow function well:
* a:Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% evaluated by echocardiography within one month of enrollment; The electrocardiogram is basically normal;
* b:Platelets ≥ 90 × 10 \^ 9/L;
* c:Hemoglobin ≥ 90g/L (no blood transfusion or erythropoietin dependence within 7 days);
* d:Total bilirubin ≤ 2 times the upper limit of normal value;
* e:Serum creatinine ≤ 1.5 times the upper limit of normal value;
* f:Transaminases (AST, ALT) ≤ 2.5 times the upper limit of normal value (if liver cancer is 5 times the upper limit of normal value);
* g:International standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 times the upper limit of normal value;
* Able to understand trial requirements and matters, willing to participate in clinical research according to trial requirements

Exclusion Criteria:

* Positive for HIV antibodies or syphilis antibodies; positive for hepatitis B surface antigen, and positive for hepatitis B core antibody or e antibody with viral DNA copy number above the detection limit or ≥1000 copies/ml; or hepatitis C virus RNA copy number above the detection limit.
* Any uncontrollable active infection, coagulation disorder, or any other major disease;
* Pregnant or lactating women;
* Suffering from active neuroautoimmune or inflammatory diseases, such as any of the following: inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, multiple sclerosis, Sjogren's syndrome, etc., and receiving relevant treatment; Subjects who are still using immunosuppressants for organ transplantation; Or subjects who have been using immunosuppressive drugs such as glucocorticoids for a long time cannot stop at least 4 weeks before enrollment; Severe allergic constitution;
* Subjects with existing abnormalities in the central nervous system, such as seizures, cerebral vascular ischemia/bleeding, dementia, cerebellar diseases, or any autoimmune diseases associated with central nervous system involvement;
* Major cardiovascular diseases with clinical significance include:

Where it's running

• Shanghai Mengchao Tumor Hospital
  Shanghai, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.