Neuroblastoma (NB)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Eligibility Criteria:?? (1) Patients with confirmed NB diagnosis via histological or radiological assessment; (2) Age =3 months; (4) Subjects receiving additional radiotherapy, targeted therapy, or immunotherapy may enroll only after completing such therapies and recovering from associated adverse events to grade =1.5×10^9/L - Platelets >=100×10^9/L - Hemoglobin >=90 g/L b) Hepatic: - Total bilirubin 35 g/L c) Renal: - Serum creatinine 60 mL/min (calculated by MDRD formula) d) Coagulation: - INR =50% confirmed by echocardiography; (7) Legally authorized representatives must provide written informed consent prior to study procedures.
Exclusion criteria
Exclusion criteria: Exclusion Criteria:?? (1) History of clinically significant comorbidities that may interfere with the study, including but not limited to: cerebrovascular accident within 6 months prior to consent, unstable angina, congestive heart failure (NYHA Class =II), uncontrolled severe arrhythmia, or other conditions potentially impacting treatment outcomes. Uncontrolled pulmonary/psychiatric disorders are excluded; (2) Concurrent malignancy (except adequately treated non-melanoma skin cancer/carcinoma in situ); (3) Active, known, or suspected autoimmune disorders; (4) Active infections: e.g., active tuberculosis, documented HIV, hepatitis B/C (HBsAg+/HCV RNA+); (5) Ongoing radiotherapy/targeted/immunotherapy, or unresolved toxicity (>Grade 1 per CTCAE v5.0) from prior therapies; (6) Having active, known or suspected autoimmune diseases; (7) Inability to comply with protocol requirements or follow-up procedures; (8) Participation in other interventional clinical trials; (9) Investigator’s judgment of clinical ineligibility.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate;Immune cell subsets;proinflammatory factor;NSE;Urine VMA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response (CR) rate;The third month after therapy;progression free survival; | — |
Countries
China
Contacts
The first affiliated hospital of Universtiy of Science and Technology of China(Anhui provincial hosptial),Anhui Provincial Cancer Hospital.