Efficacy and Safety of Radiotherapy Combined With Apatinib Mesylate in the Treatment of Rhabdomyosarcoma in Children

• Status: Unknown status
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of radiotherapy combined with apatinib mesylate in the treatment of rhabdomyosarcoma in children.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Treatments: Apatinib

Criteria

Inclusion Criteria:

• Patients must be ≥ 3 and ≤ 18 years of age.

• The predicted survival period is more than 3 months.

• According to RECIST version 1.1, there is at least one measurable lesion.

• Postoperative pathological stage was group II-IV.

• Patients have not received radiotherapy before, and can accept chemotherapy and surgical treatment.

• No other anticancer therapy should be used during radiotherapy.

• The main organs are functioning normally, which meets the following criteria:

1. Blood routine examination standards should be met: (no blood transfusion within 14 days) A.HB>90g/L; B.ANC>1.5*109/L; C.PLT>80*109/L

2. Biochemical tests should meet the following criteria:

A. BIL < 1.25 times normal upper limit (ULN); B. ALT and AST < 2.5 ULN; C. Serum Cr < 1 ULN, endogenous creatinine clearance > 50 ml/min

• Subjects volunteered to participate in this study, patients or legal guardians signed informed consent through patient consent, good compliance, with follow-up.

• Doctors believe that treatment can benefit patients.