Apatinib Plus Anti-PD1 Therapy for Advanced Osteosarcoma (APFAO)
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|ClinicalTrials.gov Identifier: NCT03359018|
Recruitment Status : Completed
First Posted : December 2, 2017
Last Update Posted : May 19, 2020
After standard multimodal therapy, the prognosis of relapsed and unresectable high-grade osteosarcoma is dismal and unchanged over the last decades. We have already finished a prospective trial about apatinib for advanced osteosarcoma(NCT02711007) and find it has a objective response rate of aproximately 45% with median progression-free survival around 5 months. Thus, the investigators explored apatinib activity together with anti-PD1 therapy in order to induce durable response in patients with relapsed and unresectable osteosarcoma after the failure of first-line or second-line chemotherapy.
Apatinib is a small-molecule vascular endothelial growth factors receptor (VEGFR) tyrosine kinase inhibitor, similar to pazopanib, but with a binding affinity 10 times to VEGFR-2 comparing with pazopanib or sorafenib.
SHR-1210 is a humanized anti-PD-1 monoclonal antibody.
|Condition or disease||Intervention/treatment||Phase|
|Progression-free Survival Overall Survival Clinical Benefit Rate Toxicity||Drug: Apatinib Drug: SHR-1210||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Every patients will received apatinib 500mg or 250mg orally daily and SHR-1210 3mg/kg (no more than 200mg) iv every 2 weeks until disease progression or intolerance to side effects|
|Masking:||None (Open Label)|
|Official Title:||Apatinib Mesylate Plus Anti-PD1 Therapy (SHR-1210) in Locally Advanced, Unresectable or Metastatic Osteosarcoma(APFAO)Refractory to Chemotherapy : a Single Institution, Open-label, Phase 2 Trial|
|Actual Study Start Date :||January 1, 2018|
|Actual Primary Completion Date :||October 22, 2019|
|Actual Study Completion Date :||January 30, 2020|
Experimental: apatinib plus anti-PD1 therapy arm
Every patients will received apatinib 250mg or 500mg orally daily and SHR-1210 3mg/kg (no more than 200mg) iv every 2 weeks until disease progression or intolerance to side effects.
Every patients will received apatinib 250mg or 500mg orally daily according to their body surface area (BSA) until disease progression or intolerance to side effects.
Every patients will received SHR-1210 3mg/kg (no more than 200mg) iv every 2 weeks until disease progression or intolerance to side effects.
- progression-free survival [ Time Frame: up to approximately 24months ]Progression-free survival is defined as time from enrollment to the first occurrence of progression of disease or death from any cause within 63 days of last response assessment.
- clinical benefit rate [ Time Frame: up to approximately 24months ]clinical benefit rate is defined as the proportion of patients who achieve disease control (objective response and stable disease according to RECIST 1.1).
- overall survival [ Time Frame: up to approximately 5 years ]overall survival is defined as the duration from date of enrollment to the date of death from any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03359018
|Musculoskeletal Tumor Center of Peking University People's Hospital|
|Beijing, China, 100044|
|Peking University Shougang Hospital|
|Beijing, China, 100144|
|Principal Investigator:||Wei Guo, M.D.and Ph.D.||Musculoskeletal Tumor Center of Peking University People's Hospital|