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NCT Number: NCT04690231

Apatinib + Ifosfamide and Etoposide for Relapsed or Refractory Osteosarcoma

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.

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Key information

Conditions

Effect of Drug Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Osteosarcoma Sarcoma Secondary Resistance Toxicity, Drug

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • histological diagnosis of osteosarcoma (confirmed by central pathological review by an expert pathologist from the Peking University People's Hospital)
  • objective disease progression within 3 months prior to treatment according to RECIST 1.1
  • previously treated with one to two lines of chemotherapy for metastatic disease
  • have an adequate performance status (adults:Eastern Cooperative Oncology Group [ECOG] performance status of 0-1;children aged >12 years: a score of ≥60% on the Karnofsky performance scale; children aged ≤12 years a score of ≥60% on the Lansky scale)

Exclusion criteria

  • a life expectancy of less than 3 months
  • patients had to have adequate bone marrow function, normal renal function, normal liver function, and normal pancreatic function
  • no other malignant tumors
  • no malignant pleural and peritoneal effusion

Treatment and study plan

Apatinib Mesylate

Drug

apatinib orally daily and ifosfamide 1.8mg/m2/d d1-3, etoposide 100mg/m2/d d1-3

Other names: ifosfamide and etoposide

ifosfamide and etoposide

Drug

ifosfamide and etoposide

Primary outcomes

  1. event-free survival

    Time frame: 24 months

    from start treatment to any events/death

Secondary outcomes

  1. progression-free survival

    Time frame: 24 months

    from start treatment to progression/death

  2. overall survival

    Time frame: 24 months

    from start treatment to death

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

  • Peking University Shougang Hospital

Registry information

Official study title

Apatinib+Ifosfamide and Etoposide (IE) Versus IE Alone for Relapsed or Refractory Osteosarcoma: a Real-world Study in Two Centers in China

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 30, 2020
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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