New Trial NCT07542912, Sintilimab Chidamide Azacitidine for ENKTL
Summary
A new open-label, single-arm, multi-center Phase II clinical trial (NCT07542912) has been registered on ClinicalTrials.gov, evaluating a sequential regimen of Sintilimab, Chidamide, and Azacitidine as first-line therapy for treatment-naïve patients with Stage I-II Extranodal NK/T-Cell Lymphoma (ENKTL). The study includes a Safety Lead-in Phase, a 2-cycle SCA Immunotherapy Induction Phase, and response-adapted consolidation therapy, followed by consolidative involved-field radiotherapy.
What changed
ClinicalTrials.gov has registered a new Phase II clinical trial (NCT07542912) for a novel first-line combination therapy targeting Extranodal NK/T-Cell Lymphoma. The trial will enroll patients into a Safety Lead-in Phase to evaluate dosing of the SCA regimen (Sintilimab, Chidamide, Azacitidine), followed by immunotherapy induction and response-adapted consolidation. Patients achieving CR or PR receive further SCA consolidation; those with SD or PD switch to P-GemOx chemotherapy, with all patients receiving consolidative radiotherapy upon completion.
Pharmaceutical sponsors of investigational oncology agents should monitor this trial for potential competitive relevance in the ENKTL indication space. Clinical investigators considering ENKTL trial participation may wish to review eligibility criteria and site locations when posted.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Sintilimab, Chidamide, and Azacitidine for Untreated Stage I-II Extranodal NK/T-Cell Lymphoma
N/A NCT07542912 Kind: NA Apr 21, 2026
Abstract
This is an open-label, single-arm, multi-center Phase II clinical trial evaluating the efficacy and safety of a novel sequential regimen as first-line therapy for treatment-naïve patients with Extranodal NK/T-cell Lymphoma (ENKTL). The study consists of a Screening Phase, a Safety Lead-in Phase, and a Treatment Phase. During the Safety Lead-in Phase, 6 patients will be enrolled to receive a fixed dose of Sintilimab and Chidamide combined with Azacitidine to verify the dose (testing 100mg/d on days 1-3 versus days 1-5). Following the lead-in, all subjects will undergo a 2-cycle Immunotherapy Induction Phase with the SCA regimen (Sintilimab, Chidamide, and Azacitidine). Subsequently, treatment will be stratified based on response: patients achieving Complete Response (CR) or Partial Response (PR) will receive 4 additional cycles of SCA consolidation, while those with Stable Disease (SD) or Progressive Disease (PD) will switch to 4 cycles of P-GemOx chemotherapy. Upon completion of systemic therapy, all patients will undergo consolidative involved-field radiotherapy (≥50Gy).
Conditions: Complete Remission Rate， CRR, Progression Free Survival, Overall Survival, Adverse Event, Duration of Response
Interventions: SCA Induction followed by Response-Adapted Therapy
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