A Single-arm, Open, Phase II Study of Chidamide Combined With Toripalimab in Refractory and Advanced Soft-tissue Sarcoma
Status:
Recruiting
Trial end date:
2022-12-30
Target enrollment:
Participant gender:
Summary
Soft tissue sarcoma is a relatively rare malignant tumor with an incidence of about
1-2/100,000. The best way to obtain evidence-based medical evidence is to participate in
clinical trials with new drugs (especially targeted drugs and immunotherapy). Chidamide, an
oral subtype-selective histone deacetylase inhibitor monotherapy was effective on the
patients with hematological tumors by inhibiting HDAC activity and other ways, showing good
anti-tumor activity. Histone deacetylase inhibitors (HDACi) may also reverse drug resistance
or inefficiency of immunoassay inhibitors, and combination therapy has shown preliminary
efficacy in a variety of tumors.Because of the poor prognosis of advanced soft tissue
sarcoma, there is no standard second-line treatment. Therefore, we think it is necessary to
explore the feasibility of combination of chidamide and Toripalimab monoclonal antibody in
advanced, refractory and progressive soft tissue sarcoma after failure of standard treatment,
and look forward to further improving the efficacy of soft tissue sarcoma.