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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Childhood Rhabdomyosarcoma

Treatments: Drug: Apatinib mesylate tablets; Radiation: Three-dimensional conformal intensity modulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03868852

XH-18-018

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

48 participants in 1 patient group

Radiotherapy plus apatinib mesylate

Experimental group

Description:

All eligible patients signed informed consent. Three-dimensional conformal intensity modulation (IMRT) technique was used to treat the patients with radiation doses 45 Gy - 54 Gy. All patients took apatinib mesylate tablets 250 mg QD orally from 1 week before radiotherapy to the whole radiotherapy period. They were required to take apatinib mesylate tablets with warm boiling water half an hour after meal. The daily medication time should be as consistent as possible.

Treatment:

Radiation: Three-dimensional conformal intensity modulation

Drug: Apatinib mesylate tablets