NCT05638984 is a Phase 2 clinical trial of Decitabine Injection in PFS, sponsored by Fudan University.

Who is sponsoring NCT05638984?

NCT05638984 is sponsored by Fudan University.

What drugs are being tested in NCT05638984?

Interventions in NCT05638984: Decitabine Injection, tirelizumab.

Is NCT05638984 still recruiting?

NCT05638984 is currently status unknown. Last updated 6 December 2022.

Last reviewed 2022-12-06 · How we verify

NCT05638984

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Low Dose Decitabine in Combination With Tirelizumab Comparison of Tirelizumab in the First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma

Status unknown Phase 2 Last updated 6 December 2022

What this trial tests

Phase 2 trial testing Decitabine Injection in PFS in 60 participants. Status unknown.

Timeline

1 January 2023

Primary endpoint
31 December 2023

31 December 2024

Quick facts

Lead sponsor	Fudan University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 January 2023
Primary completion	31 December 2023
Estimated completion	31 December 2024

Drugs / interventions tested

Decitabine Injection — full drug profile →
tirelizumab — full drug profile →

Conditions studied

PFS — all drugs for PFS →

Sponsor

Fudan University

Who can join

18 and older, any sex, with PFS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To evaluate the efficacy and safety of low-dose decitabine combined with tirelizumab in the treatment of patients with advanced esophageal squamous cell carcinoma who did not progress in first-line immunotherapy combined with chemotherapy.

Publications & conference data

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

Reshaping the tumour immune microenvironment in solid tumours via tumour cell and immune cell DNA methylation: from mechanisms to therapeutics.
Zhong F, Lin Y, Zhao L, Yang C, et al · · 2023 · cited 40× · PMID 37117649 · DOI 10.1038/s41416-023-02292-0
The interaction between DNA methylation and tumor immune microenvironment: from the laboratory to clinical applications.
Zhu D, Zeng S, Su C, Li J, et al · · 2024 · cited 32× · PMID 38331927 · DOI 10.1186/s13148-024-01633-x
The epigenetic hallmarks of immune cells in cancer.
Ji Y, Xiao C, Fan T, Deng Z, et al · · 2025 · cited 28× · PMID 40038722 · DOI 10.1186/s12943-025-02255-4

Verify or expand the search:

Other trials of Decitabine Injection

Trials testing the same drug.

NCT06499025 — Treatment of Relapsed or Refractory t(8; 21) AML With Targeted AML1-ETO Neoantigen Cytotoxic T Cells (CTL) · EARLY_PHASE1 · enrolling by invitation

Other Fudan University trials

Trials by the same sponsor.

NCT06196671 — Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer · Phase 2 · not yet recruiting
NCT07423611 — ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer · Phase 2 · not yet recruiting
NCT07410559 — Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Bre · Phase 2 · not yet recruiting
NCT07490119 — Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer · Phase 2 · not yet recruiting
NCT07497919 — A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05638984 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fudan University
Last refreshed: 6 December 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05638984.

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