NCT04294511

Study of Camrelizumab in Combination With Neoadjuvant Chemotherapy in the Treatment of Osteosarcoma

A Phase Ⅱ ,Open-label ,Single Institution Study to Investigate the Efficacy and Safety of Camrelizumab in Combination With Neoadjuvant Chemotherapy in the Treatment of Locally , Resectable Osteosarcoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is a open-lable, , single center, phase II clinical study. Target population is patients with locally resectable osteosarcoma. Study objective is to compare the efficacy and safety of camrelizumab in combination with adriamycin, cisplatin, ifosfamide and methotrexate in study population in China. Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody.

Detailed description

In this study, eligible subject will be enrolled into study arm to accept study treatment. Treatment cycles of chemotherapy will be at most 9 cycles which will be decided by investigators. The percentage of the patient with tumor cell necrosis rate \>90% determined by the Independent Review Committee (IRC) will be the primary outcome measures.

Conditions

• Osteosarcoma

Interventions

Type	Name	Description
DRUG	Camrelizumab in Combination With Neoadjuvant Chemotherapy	camrelizumab in combination with adriamycin, cisplatin, ifosfamide and methotrexate

Timeline

• Start date: 2019-12-26
• Primary completion: 2021-03-16
• Completion: 2023-09-16
• First posted: 2020-03-04
• Last updated: 2020-03-04

Locations

1 site across 1 country: China