Apatinib + Ifosfamide and Etoposide for Relapsed or Refractory Osteosarcoma

Sponsor
Peking University People's Hospital
Study ID
NCT04690231
Status
Completed

Conditions

  • Effect of Drug
  • Secondary Resistance
  • Toxicity, Drug

Eligibility Criteria

Sex
ALL
Age
3 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apatinib Mesylate — DRUG
    apatinib orally daily and ifosfamide 1.8mg/m2/d d1-3, etoposide 100mg/m2/d d1-3
  • ifosfamide and etoposide — DRUG
    ifosfamide and etoposide

Study Details

Today, using a multi-modal approach consisting of preoperative (neoadjuvant) systemic polychemotherapy followed by local surgical therapy and then postoperative (adjuvant) chemotherapy, long-term, disease-free survival can be achieved in 60- 70% of osteosarcoma patients. However treatment options for osteosarcomas, especially in the setting of metastatic or unresectable disease, are very scarce. Apatinib has been proved to be an effective agent to prolong progression-free survival in advanced osteosarcoma. But after 4-6 months' treatment, secondary resistance always occurred with musculoskeletal lesions' progression or new metastasis. Nowadays giving therapeutic doses of IE concurrently with anti-angiogenesis tyrosine kinase inhibitors is a conceptually attractive strategy for treating patients with refractory osteosarcoma according to prospective trial of lenvatinib +IE reported by Gaspar et al at 2019 ESMO and 2020 ESMO. Thus This study was designed to review our experience in real world for off-label use and characterize the toxicity profile of concurrent apatinib+IE and IE alone in patients with relapsed or refractory osteosarcoma.

Key Dates

Start date
Dec 1, 2020
Status verified
Mar 2022
Primary completion
Mar 1, 2021
Completion
Jun 1, 2021

Study Design

Enrollment
79 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib+IE
  • Active Comparator: IE

Primary Outcome Measure

event-free survival [ Time Frame: 24 months ]

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