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

Launched by XINHUA HOSPITAL, SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Mar 7, 2019

Keywords

ClinConnect Summary

This study is a Interventional study. The target group was 3-18 years old, and the pathological stage was group II-IV recurrence or distant metastasis. A total of 48 patients were enrolled in this study. The treatment was radiotherapy combined with apatinib. The main outcome measures were ORR, DCR , OS , quality of life and drug safety. The main safety indicators were vital signs, laboratory indicators, adverse events (AE), and severe adverse events (SAE). This study is expected to be enrolled for 6 months.

Gender

ALL

Eligibility 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.