Efficacy and Safety of Anlotinib, Irinotecan and Temozolomide in the Treatment of Refractory or Recurrent Neuroblastoma in Children: an Open, Single Arm, Single Center, Phase II Clinical Study

Conditions

• Refractory or Recurrent Neuroblastoma in Children

Eligibility Criteria

Sex

ALL

Age

0 Years - 21 Years

Healthy Volunteers

Not accepted

Interventions

• Anlotinib and irinotecan combined with temozolomide — DRUG
  Anlotinib, 7mg/m2, PO, was given for 14 days and stopped for 7 days; Irinotecan, 50mg/m2, D1-5, IV; Temozolomide, 100mg/m2, d1-5, PO; Three weeks is a cycle.

Study Details

Neuroblastoma is an embryonal tumor originated from primitive neural crest cells. It is the most common extracranial solid tumor in children. It is characterized by abundant blood vessels, rapid growth and early metastasis.With the gradual improvement of diagnosis and treatment technology, the survival rate of children with Neuroblastoma in China has been increasing year by year, but the Overall Survival is still lower than that in European and American countries, so new and efficient treatment methods are urgently needed in clinical practice.Anti-angiogenesis target therapy is an important component of the malignant tumor treatment, hydrochloric acid for Anlotinib has the anti-tumor angiogenesis and suppress tumor growth, Anlotinib currently in thyroid carcinoma, esophageal cancer, liver cancer, colorectal cancer, soft nest, cervical cancer, soft tissue sarcoma and so on the many kinds of cancer are conducting clinical trials, but in neuroblastoma application has not been reported.The purpose of this study was to explore the therapeutic effect and mechanism of Anlotinib and irinotecan combined with temozolomide in the treatment of refractory or recurrent Neuroblastoma in children.Neuroblastoma is an embryonal tumor originated from primitive neural crest cells. It is the most common extracranial solid tumor in children. It is characterized by abundant blood vessels, rapid growth and early metastasis.It accounts for 8%-10% of all malignant tumors in children, with an annual incidence of 0.3-5.5/100,000.The prognosis of Neuroblastoma was closely related to age at diagnosis, clinical stage, tumor pathological type, N-myc gene copy number and DNA index.According to the above five indicators, the Children's Oncology Group divided NB into low, medium and high risk groups.According to the 2013 Children's Oncology Group data, the current 5-year Overall Survival of low - and moderate-risk Neuroblastoma patients was 90%, while the Overall Survival of high-risk patients was only 50%.The current treatment of Neuroblastoma is a multidisciplinary combination of surgery, chemoradiotherapy and autologous stem cell transplantation.With the gradual improvement of diagnosis and treatment technology, the survival rate of children with NB in China has been increasing year by year, but the Overall Survival is still lower than that in European and American countries, so new and efficient treatment methods are urgently needed in clinical practice.

Key Dates

Start date

Apr 12, 2021

Status verified

Feb 2021

Primary completion

Dec 31, 2023

Completion

Dec 31, 2023

Study Design

Enrollment

27 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Anlotinib and irinotecan combined with temozolomide

Primary Outcome Measure

progression-free survival [ Time Frame: up to six months ]