Neoplasms

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Rare Diseases

Osteosarcoma

Disease Progression

Disease Attributes

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Sarcoma

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Ifosfamide

Isophosphamide mustard

Antineoplastic Agents, Alkylating

Alkylating Agents

In the dose-defining phase I portion, camrelizumab was given at a fixed dose of 200mg Q2W, while the de-escalated 3+3 design was used to detect the recommended dose of famitinib from an initial level of 15mg orally taken daily. Recommended phase 2 dose (RP2D) was defined as the highest dose at which no more than 30% patients experience a DLT in the first two courses.

In the phase II portion, famitinib will be orally taken daily with RP2D together with camrelizumab intravenous infusion at a dose of 200 mg over 30 minutes, once every two weeks (Q2W), 4 weeks (28 days) as one treatment cycle.

Only phase II portion (Phase I have been completed): famitinib will be 20mg orally taken daily, 4 weeks (28 days) as one treatment cycle.

Only phase II protion (Phase I have been completed): famitinib will be 20mg orally taken daily, 4 weeks (28 days) as one treatment cycle together with ifofamide 1800 mg/m\^2/day intravenous infusion will be administered on Days 1 to 3 and 15-17 of each 28-day cycle for a total of 5 cycles.

Famitinib

ifosfamide 1.8g/m2/d d1-3, 15-17 Q4W infusion

Camrelizumab

Wei Guo, Ph.D. and M.D.

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.

Famitinib Plus Camrelizumab & Famitinib Alone & Famitinib Plus Ifosfamide in Advanced Osteosarcoma

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

Progression-free survival is defined as time from randomisation to the first occurrence of progression of disease or death from any cause within 63 days of last response assessment or randomisation.

Overall survival is was defined as time from randomisation to the first occurrence of death from any cause within 63 days of last response assessment or randomisation. randomisation to the first occurrence of progression of disease orrandomisation.

Duration of response is defined as from the time of occurence of best overall response to progression or death for the proportion of patients achieving an overall response.

Spots Global Cancer Trial Database for advanced osteosarcoma