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

Sponsor
Peking University People's Hospital
Study ID
NCT04824352
Phase
PHASE2
Status
Suspended

Conditions

  • Effect of Drug
  • Toxicity, Drug

Eligibility Criteria

Sex
ALL
Age
12 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • apatinib — DRUG
    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

Study Details

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.

Key Dates

Start date
Apr 1, 2021
Status verified
May 2024
Primary completion
Apr 1, 2026
Completion
Apr 1, 2026

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: apatinib+IE
    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

Primary Outcome Measure

Progression free survival [ Time Frame: 2 years ]

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