Famitinib Plus Camrelizumab & Famitinib Alone & Famitinib Plus Ifosfamide in Advanced Osteosarcoma
Summary
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.
Timeline
- Start
- 2019-08-15
- Primary completion
- 2021-09-30
- Completion
- 2022-09-30
Publications
- Background 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.
- Background Xie L, Guo W, Wang Y, Yan T, Ji T, Xu J. Apatinib for advanced sarcoma: results from multiple institutions' off-label use in China. BMC Cancer. 2018 Apr 6;18(1):396. doi: 10.1186/s12885-018-4303-z.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Camrelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Famitinib | Small molecule | 15 mg | Oral |
| Subject | Famitinib | Small molecule | 20 mg | Oral |
| Subject | Ifosfamide | Small molecule | 1.8 g | Intravenous |