NCT04025931

Chidamide Combined With Toripalimab in Sarcoma

Status unknown Phase 2 Last updated 29 December 2023

What this trial tests

Phase 2 trial testing chidamide and toripalimab in Sarcoma in 74 participants. Status unknown.

Timeline

19 January 2020

Primary endpoint
30 December 2023

30 December 2024

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	74
Start date	19 January 2020
Primary completion	30 December 2023
Estimated completion	30 December 2024
Sites	1 location across China

Drugs / interventions tested

• chidamide and toripalimab — full drug profile →

Conditions studied

• Sarcoma — all drugs for Sarcoma →

Sponsor

Sun Yat-sen University

Who can join

Adults 14 to 70, any sex, with Sarcoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent developments in epigenetic cancer therapeutics: clinical advancement and emerging trends.
   Nepali K, Liou JP. · · 2021 · cited 122× · PMID 33840388 · DOI 10.1186/s12929-021-00721-x
2. Regulation and signaling pathways in cancer stem cells: implications for targeted therapy for cancer.
   Zeng Z, Fu M, Hu Y, Wei Y, et al · · 2023 · cited 93× · PMID 37853437 · DOI 10.1186/s12943-023-01877-w
3. Improving Immunotherapy Efficacy in Soft-Tissue Sarcomas: A Biomarker Driven and Histotype Tailored Review.
   Roulleaux Dugage M, Nassif EF, Italiano A, Bahleda R. · · 2021 · cited 73× · PMID 34925348 · DOI 10.3389/fimmu.2021.775761
4. Therapeutic potential of tucidinostat, a subtype-selective HDAC inhibitor, in cancer treatment.
   Sun Y, Hong JH, Ning Z, Pan D, et al · · 2022 · cited 58× · PMID 36120308 · DOI 10.3389/fphar.2022.932914
5. Short-chain acyl post-translational modifications in cancers: Mechanisms, roles, and therapeutic implications.
   Wu T, Zhao Y, Zhang X, Wang Y, et al · · 2025 · cited 23× · PMID 40703012 · DOI 10.1002/cac2.70048
6. Hypoxic tumor microenvironment: Destroyer of natural killer cell function.
   Zhang Y, Guo F, Wang Y. · · 2024 · cited 13× · PMID 38751439 · DOI 10.21147/j.issn.1000-9604.2024.02.04
7. The Sarcoma Immune Landscape: Emerging Challenges, Prognostic Significance and Prospective Impact for Immunotherapy Approaches.
   Koumarianou A, Duran-Moreno J. · · 2021 · cited 13× · PMID 33498238 · DOI 10.3390/cancers13030363
8. A review of the therapeutic potential of histone deacetylase inhibitors in rhabdomyosarcoma.
   Selim O, Song C, Kumar A, Phelan R, et al · · 2023 · cited 9× · PMID 37664028 · DOI 10.3389/fonc.2023.1244035