Clinical Trial

Sintilimab, Chidamide, and Azacitidine for Untreated Stage I-II Extranodal NK/T-Cell Lymphoma

Study acronym: SCENT-3
Not Yet Recruiting
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Summary
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).
Trial Details
NCT Number NCT07542912
Lead Sponsor Sun Yat-sen University
Conditions Complete Remission Rate, CRR, Progression Free Survival, Overall Survival, Adverse Event, Duration of Response
Enrollment 30 participants
Start Date 2026-06-01
Primary Completion 2029-06-01 (estimated)
Study Completion 2029-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-21