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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04690231
Other study ID # PKUPH-sarcoma 14
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date June 1, 2021

Study information

Verified date March 2022
Source Peking University People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date June 1, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers No
Gender All
Age group 3 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Peking University People's Hospital Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
Peking University People's Hospital Peking University Shougang Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Xie L, Xu J, Sun X, Tang X, Yan T, Yang R, Guo W. Apatinib for Advanced Osteosarcoma after Failure of Standard Multimodal Therapy: An Open Label Phase II Clinical Trial. Oncologist. 2019 Jul;24(7):e542-e550. doi: 10.1634/theoncologist.2018-0542. Epub 2018 Dec 17. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary event-free survival from start treatment to any events/death 24 months
Secondary progression-free survival from start treatment to progression/death 24 months
Secondary overall survival from start treatment to death 24 months
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