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OncoMatch/Clinical Trials/NCT06824883

Sintilimab, Pegaspargase Plus GemOx for Untreated Extranodal NK/T-Cell Lymphoma

Is NCT06824883 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Immunochemotherapy for extranodal nk/t-cell lymphoma.

Phase 2RecruitingPeking Union Medical College HospitalNCT06824883Data as of May 2026

Treatment: ImmunochemotherapyThis is a single-arm phase 2 study designed to evaluate the safety and efficacy of sintilimab, pegaspargase combined with gemcitabine and oxaliplatin (P-P-GEMOX regimen) as first-line treatment for patients with ENKTL. The primary endpoint is the complete response rate (CRR) in the intention-to-treat population.The secondary endpoints were overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and adverse events.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Performance status

ECOG 0–3(Limited self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Lab requirements

Blood counts

ANC ≥ 1.5 × 10⁹/L (≥ 1.0 × 10⁹/L with bone marrow involvement); PLT ≥ 80 × 10⁹/L (≥ 50 × 10⁹/L with bone marrow involvement); HGB ≥ 80 g/L

Kidney function

Serum creatinine < 1.5 × ULN

Liver function

ALT < 3 × ULN; TBil < 1.5 × ULN

Cardiac function

NYHA heart function class 0-2; LVEF > 50%

Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L (≥ 1.0 × 10⁹/L in cases with bone marrow involvement); Platelet count (PLT) ≥ 80 × 10⁹/L (≥ 50 × 10⁹/L in cases with bone marrow involvement); Hemoglobin (HGB) ≥ 80 g/L. Adequate organ function: Alanine aminotransferase (ALT) < 3 × the upper limit of normal (ULN); Total bilirubin (TBil) < 1.5 × ULN; Serum creatinine < 1.5 × ULN; NYHA heart function class 0-2; Left ventricular ejection fraction (LVEF) > 50%.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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