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Study on differences in intestinal flora of patients with relapsed/refractory neuroblastoma in children with different responses to irinotecan combined with temozolomide

Study on differences in intestinal flora of patients with relapsed/refractory neuroblastoma in children with different responses to irinotecan combined with temozolomide

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000036967
Enrollment
Unknown
Registered
2020-08-25
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent/refractory neuroblastoma in children

Interventions

experimental group:Irinotecan combined with temozolomide
healthy control group:Nil

Sponsors

Xinhua Hospital affiliated to Shanghai Jiao Tong University School Of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: (1) 1 year old < age <= 18 years old; (2) Biopsy histopathological and immunohistochemical detection of neuroblastoma with reference to the diagnostic criteria for neuroblastoma recommended by COG, pathological classification (INPC) and international Neuroblastoma staging (INSS); (3) Recurrent NB means new lesions appearing in the primary or other places 4 weeks after CR arrival through multidisciplinary comprehensive treatment, and refractory NB is defined as the evaluation of curative effect through 2 to 4 courses of chemotherapy and progression disease (PD); (4) ECOG scale (ECOG-PS) <= 2; (5) Expected survival for at least 3 months; (6) Agree to the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) No antibiotics or gastrointestinal surgery was performed within 3 months. Use (e.g., sulfamethoxazole/trimethoprim) is permitted to prevent pneumocystis carinii pneumonia. (2) Patients with autoimmune diseases. (3) Patients with immunodeficiency. (4) Patients with recurrent/refractory diseases who have been treated. (5) Multiple organ failure. (6) Uncontrolled infection and diarrhea. (7) Drug allergy.

Design outcomes

Primary

MeasureTime frame
Intestinal microbiota ;Chemotherapy response: complete response,very good partial response,partial response,mixed response,no response,stable disease and progressive disease.;

Countries

China

Contacts

Public ContactZhang Xin

Xinhua Hospital affiliated to Shanghai Jiao Tong University School Of Medicine

398788775@qq.com+86 13560792312

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026