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COMPLETED
NCT04025931
PHASE2

Chidamide Combined With Toripalimab in Sarcoma

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

Official title: A Single-arm, Multi-center, Open, Phase II Study of Chidamide Combined With Toripalimab in Refractory and Advanced Soft-tissue Sarcoma

Key Details

Gender

All

Age Range

14 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

73

Start Date

2020-01-19

Completion Date

2026-04-28

Last Updated

2026-06-12

Healthy Volunteers

No

Conditions

Interventions

DRUG

chidamide and toripalimab

The eligible patients with advanced soft tissue sarcoma were treated with chidamide combined with toripalimb. Chidamide 30mg orally twice a week; Toripalimab 240 mg (fixed dose) every three weeks. Repeat every three weeks. Patients with disease control (CR + PR + SD) and tolerable adverse reactions continued to take medication until the researchers concluded that patients were not suitable to continue medication or the efficacy evaluation was disease progression (PD). No other antineoplastic treatment can be given during the treatment.

Locations (1)

Sun Yat-Sen Univerisity

Guangzhou, Guangdong, China