Pediatric Cancer Clinical Trial
Official title:
Famitinib Malate (SHR1020) Plus Camrelizumab (SHR 1210) Versus Famitinib Malate Alone Versus Famitinib Malate Plus Ifosfamide Locally Advanced, Unresectable or Metastatic Osteosarcoma Progression Upon Chemotherapy: A Phase Ib/II Randomized and Controlled Dose-Escalation Trial
Results of previous study showed high objective response but short-term activity of
anti-angiogenesis tyrosine kinase inhibitors in advanced osteosarcoma. Given the recent
success of immunotherapies, combinations of antiangiogenics with immune checkpoint blockers
have become an attractive strategy. The investigators had completed an prospective phase 2
trial of the combination of apatinib and camrelizumab on advanced osteosarcoma and showed
prolonged progression-free survival for this combination. Famitinib is a novel tyrosine
kinase inhibitor targeting VEGFR-2, -3 and FGFR-1, -2, -3, -4 with high affinity, which
showed broad antitumor activity against a variety of xenograft models.
A Study to Compare the Efficacy and Safety of Levatinib with or without Ifosfamide and
Etoposide in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma
showed promising median PFS of 11.3 months. Thus we also try to investigate the combination
efficacy of TKIs with chemotherapy in advanced osteosarcoma.
This study aims to investigate the recommended phase 2 dose for pediatric use of famitinib in
combination with camrelizumab and trys to explore the efficacy and safety for single drug
famitinib, famitinib and camrelizumab and famitinib and ifosfamide in patients with
inoperable high-grade osteosarcoma progressing after chemotherapy.
n/a
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