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NCT06583083: SPIRIT-02
Sintilimab With P-GEMOX Versus the P-GEMOX in the Teatment of Advanced-stage Extranodal Natural Killer/T Cell Lymphoma
Phase 2 trial testing Sintilimab with P-GEMOX Regimen in Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type in 84 participants. Currently enrolling.
28 August 2026
Quick facts
| Lead sponsor | Sun Yat-sen University |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 84 |
| Start date | 22 October 2024 |
| Primary completion | 28 August 2026 |
| Estimated completion | 28 August 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Sintilimab with P-GEMOX Regimen — full drug profile →
- P-GEMOX Regimen
Conditions studied
- Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type — all drugs for Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type →
Sponsor
Sun Yat-sen University
Who can join
18 and older, any sex, with Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Extranodal NK/T-cell lymphoma is a rare and highly aggressive subtype of non-Hodgkin lymphoma. While the overall survival rates have improved for early-stage ENKTL patients, the prognosis for those with advanced disease remains poor, and there is currently no standard treatment. PD-1/PD-L1 inhibitors have demonstrated significant efficacy in various cancers, and recent studies have shown promising results in extranodal NK/T-cell lymphoma as well. Although PD-1 antibodies have exhibited efficacy in relapsed or refractory patients, their effectiveness when combined with chemotherapy as a first-line treatment remains unclear. This study aims to evaluate the efficacy and safety of sintilimab combined with chemotherapy in a randomized controlled trial for newly diagnosed advanced extranodal NK/T-cell lymphoma patients, while also exploring potential biomarkers that may predict treatment outcomes, offering new therapeutic options for extranodal NK/T-cell lymphoma patients.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Immunotherapy in NK/T-Cell Lymphoma: Mechanisms, Clinical Evidence, Resistance, and Emerging Multimodal Strategies.
Zhang Q, Wang X. · · 2026 · PMID 42122154 · DOI 10.3390/cancers18091358
Verify or expand the search:
- PubMed search for NCT06583083
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
Currently open trials in the same condition.
- NCT06376721 — Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma · Phase 1, PHASE2 · recruiting
- NCT06314334 — Screening Study of Combined Sequential Chemotherapy and Radiation Therapy for Early-stage NK/T-cell Lymphoma · Phase 2 · recruiting
Other Sun Yat-sen University trials
Trials by the same sponsor.
- NCT07255612 — Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negat · Phase 2 · not yet recruiting
- NCT07371897 — Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial · Phase 3 · not yet recruiting
- NCT07489703 — SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC · Phase 2 · not yet recruiting
- NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
- NCT07522281 — Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles · NA · 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)
- Trial protocol + status: ClinicalTrials.gov NCT06583083 (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 Sun Yat-sen University
- Last refreshed: 14 April 2026
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/NCT06583083.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing