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Apatinib Plus IE Chemotherapy (Ifosfamide and Etoposide) for Relapsed or Refractory Osteosarcoma

NCT04824352 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-05-14

No results posted yet for this study

Summary

Apatinib has led to positive responses in the treatment of osteosarcoma refractory to first-line chemotherapy. However, apatinib demonstrates only short-lived activity, and the disease control of musculoskeletal lesions is worse than that of pulmonary lesions. This treatment failure has been partly overcome by the addition of ifosfamide and etoposide (IE). We have ever retrospectively compared the activity of apatinib + IE in relapsed or refractory osteosarcoma in two sarcoma centers in China and concluded that for osteosarcoma with multiple sites of metastasis, apatinib + IE demonstrated clinically meaningful antitumor activity and delayed disease progression in patients with recurrent or refractory osteosarcoma after failure of chemotherapy. However to overcome the influence of other interventions on the outcome, we are currently performing a prospective trial to investigate this combination, from which more accurate data on this treatment strategy are expected.

Conditions

  • Effect of Drug
  • Toxicity, Drug

Interventions

DRUG

apatinib

Apatinib: 500 mg QD po (BSA ≥ 1.0) or 250 mg QD po (BSA \< 1.0); IE: ifosfamide 1.8 g/m2/d d1-3; etoposide 100 mg/m2/d d1-3 Q2w

Sponsors & Collaborators

  • Peking University Shougang Hospital

    collaborator OTHER

  • Peking University People's Hospital

    lead OTHER

Principal Investigators

  • Wei Guo, M.D. · Musculoskeletal Tumor Center of Peking University People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2026-04-01
Completion
2026-04-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04824352 on ClinicalTrials.gov