Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 80Years
All Genders
NCT07146672

Exploratory Study of Super DC Cell Injection in Preventing Recurrence After Radical Surgery for Tumors

Led by Shanghai Cell Therapy Group Co.,Ltd · Updated on 2025-08-28

12

Participants Needed

1

Research Sites

74 weeks

Total Duration

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AI-Summary

What this Trial Is About

The study is a controlled, open-label exploratory clinical trial.

CONDITIONS

Official Title

Exploratory Study of Super DC Cell Injection in Preventing Recurrence After Radical Surgery for Tumors

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 80 years old, weight 40kg or more; no gender limit
  • Diagnosed with malignant solid tumors by histology or cytology and undergone radical surgery
  • No lesions, local recurrence, or distant metastasis on imaging at study start; no brain metastasis
  • For safety verification, positive immunohistochemical test for Survivin, P53, or MUC1
  • ECOG performance status score of 0-1
  • Adequate veins and no contraindications for blood cell collection surgery
  • Good organ and bone marrow function including:
  • Cardiac: Left ventricular ejection fraction at least 50%, normal electrocardiogram
  • Platelets at least 90 x 10^9/L
  • Hemoglobin at least 90 g/L without recent transfusion or erythropoietin dependence
  • Total bilirubin no more than twice the upper normal limit
  • Serum creatinine no more than 1.5 times the upper normal limit
  • Transaminases (AST, ALT) no more than 2.5 times upper limit (5 times for liver cancer)
  • INR or prothrombin time no more than 1.5 times upper limit
  • Able to understand and willing to follow trial requirements
Not Eligible

You will not qualify if you...

  • Positive for HIV or syphilis antibodies
  • Positive hepatitis B surface antigen and core or e antibody with viral DNA above detection limit or 1000 copies/ml
  • Positive hepatitis C virus RNA above detection limit
  • Any uncontrolled active infection, clotting disorder, or other major disease
  • Pregnant or lactating women
  • Active neuroautoimmune or inflammatory diseases (e.g., inflammatory bowel disease, lupus, ankylosing spondylitis, scleroderma, multiple sclerosis, Sjogren's syndrome) and receiving treatment
  • Current use of immunosuppressants for organ transplant or long-term glucocorticoids not stopped at least 4 weeks before enrollment
  • Severe allergies
  • Central nervous system abnormalities such as seizures, strokes, dementia, cerebellar diseases, or autoimmune CNS diseases
  • Major cardiovascular diseases with clinical significance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shanghai Mengchao Tumor Hospital

Shanghai, China

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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