Apatinib With Ifosfamide Plus Etoposide for Relapsed or Refractory Osteosarcoma (OAIE)

Sponsor
Peking University People's Hospital
Study ID
NCT05277480
Phase
PHASE2
Status
Completed

Conditions

  • Drug
  • Effect of Drug
  • Toxicity

Eligibility Criteria

Sex
ALL
Age
12 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib+IE — DRUG
    apatinib po； ifosfamide ivgtt ; etoposide ivgtt .
  • IE — DRUG
    ifosfamide ivgtt ; etoposide ivgtt .

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
Mar 1, 2022
Status verified
Jul 2024
Primary completion
Jun 30, 2023
Completion
Nov 26, 2023

Study Design

Enrollment
81 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib+IE group
    IE: Ifosfamide Plus Etoposide
  • Active Comparator: IE group
    IE: Ifosfamide Plus Etoposide

Primary Outcome Measure

Progression free survival [ Time Frame: 2 years ]

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