NCT04651127

Anti-PD-1 Antibody Combined With Histone Deacetylase Inhibitor in Patients With Advanced Cervical Cancer

Terminated Phase 1, PHASE2 Last updated 10 March 2026

What this trial tests

Phase 1, PHASE2 trial testing Toripalimab + Chidamide in Cervical Cancer in 5 participants. Terminated before completion.

Timeline

9 November 2020

Primary endpoint
26 January 2023

26 January 2023

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	9 November 2020
Primary completion	26 January 2023
Estimated completion	26 January 2023
Sites	1 location across China

Drugs / interventions tested

• Toripalimab + Chidamide — full drug profile →

Conditions studied

• Cervical Cancer — all drugs for Cervical Cancer →
• Cervix Cancer — all drugs for Cervix Cancer →
• Cervix Neoplasm — all drugs for Cervix Neoplasm →

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 70, female only, with Cervical Cancer or Cervix Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cervical cancer is the second-most common cancer in the world and is a leading cause of cancer death among women in developing countries. Cisplatin-based chemotherapy +/- bevacizumab have been recommended as the first-line treatment for patients who present with metastatic (e.g. stage IVB), persistent, or recurrent cervical cancer. However, patients in this setting are rarely curable. Pembrolizumab has been approved for second-line treatment in patients with advanced PD-L1-positive cervical cancer. However, the response rate achieved by PD-1 inhibitors as monotherapy is only modest. Preclinical studies found that in mouse models of B-cell lymphoma, adding a histone deacetylase (HDAC) inhibitor sensitized cancers to anti-PD-1 therapy. Recently, combination treatment of HDAC inhibitors with immune checkpoint inhibitors is widely investigated and has promising results in several cancer types. Toripalimab is a humanized IgG4 monoclonal antibody against PD-1. Chidamide is a class I HDAC inhibitor. Here we conducted a phase Ib/II, single-arm, multi-center study to evaluate the efficacy and safety of toripalimab in combination with chidamide in patients with metastatic, persistent, or recurrent cervical cancer.

Publications & conference data

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

1. Immunosuppressive cells in cancer: mechanisms and potential therapeutic targets.
   Tie Y, Tang F, Wei YQ, Wei XW. · · 2022 · cited 386× · PMID 35585567 · DOI 10.1186/s13045-022-01282-8
2. Understanding the immunosuppressive microenvironment of glioma: mechanistic insights and clinical perspectives.
   Lin H, Liu C, Hu A, Zhang D, et al · · 2024 · cited 232× · PMID 38720342 · DOI 10.1186/s13045-024-01544-7
3. Epigenetic modulation of antitumor immunity for improved cancer immunotherapy.
   Dai E, Zhu Z, Wahed S, Qu Z, et al · · 2021 · cited 224× · PMID 34930302 · DOI 10.1186/s12943-021-01464-x
4. 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
5. Novel Approaches to Epigenetic Therapies: From Drug Combinations to Epigenetic Editing.
   Majchrzak-Celińska A, Warych A, Szoszkiewicz M. · · 2021 · cited 85× · PMID 33572577 · DOI 10.3390/genes12020208
6. 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
7. Mechanisms of immune modulation in the tumor microenvironment and implications for targeted therapy.
   Czajka-Francuz P, Prendes MJ, Mankan A, Quintana Á, et al · · 2023 · cited 46× · PMID 37427115 · DOI 10.3389/fonc.2023.1200646
8. Small-molecule agents for cancer immunotherapy.
   Wang F, Fu K, Wang Y, Pan C, et al · · 2024 · cited 41× · PMID 38486980 · DOI 10.1016/j.apsb.2023.12.010