Efficacy and Safety Study of Cardunilizumab in Soft Tissue Sarcoma

Summary

The goal of this type of study: clinical trial is to observe the efficacy and safety of cardunilizumab in soft tissue sarcomas after failure of at least first-line anthracycline-based chemotherapeutic agents, including undifferentiated sarcoma (UPS), smooth muscle sarcoma, mucinous fibrosarcoma, and poorly differentiated/undifferentiated/polymorphic liposarcoma, etc.) . The main question\[s\] it aims to answer are: * Cardunilizumab is effective in soft tissue sarcomas after failure of at least first-line anthracycline-based chemotherapeutic agents, including undifferentiated sarcoma (UPS),smooth muscle sarcoma, mucinous fibrosarcoma, and poorly differentiated/undifferentiated/polymorphic liposarcoma) is effective . * Cardunilizumab has manageable adverse effects. Participants will be given Cardunolizumab 6mg/kg once every 2 weeks free

Timeline

Start

2022-11-01

Primary completion

2023-06-30

Completion

2024-11-30

Publications

• Results Savina M, Le Cesne A, Blay JY, Ray-Coquard I, Mir O, Toulmonde M, Cousin S, Terrier P, Ranchere-Vince D, Meeus P, Stoeckle E, Honore C, Sargos P, Sunyach MP, Le Pechoux C, Giraud A, Bellera C, Le Loarer F, Italiano A. Patterns of care and outcomes of patients with METAstatic soft tissue SARComa in a real-life setting: the METASARC observational study. BMC Med. 2017 Apr 10;15(1):78. doi: 10.1186/s12916-017-0831-7.
• Results Tawbi HA, Burgess M, Bolejack V, Van Tine BA, Schuetze SM, Hu J, D'Angelo S, Attia S, Riedel RF, Priebat DA, Movva S, Davis LE, Okuno SH, Reed DR, Crowley J, Butterfield LH, Salazar R, Rodriguez-Canales J, Lazar AJ, Wistuba II, Baker LH, Maki RG, Reinke D, Patel S. Pembrolizumab in advanced soft-tissue sarcoma and bone sarcoma (SARC028): a multicentre, two-cohort, single-arm, open-label, phase 2 trial. Lancet Oncol. 2017 Nov;18(11):1493-1501. doi: 10.1016/S1470-2045(17)30624-1. Epub 2017 Oct 4.

Drugs

Indications