Clinical trial · Interventional
Radiotherapy and Anti-PD-1 in Low-risk ES-ENKTCL
Radiotherapy With Inductive and Concurrent Anti-PD-1 Antibody in Early-stage Low-risk Extranodal NK/T Cell Lymphoma, Nasal Type: A Multi-center Phase II Study
NCT05149170CI-TRIAL-00055428unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of adding Anti-PD-1 antibody in an inductive and concurrent way to radiotherapy in early-stage low-risk extranodal NK/T cell lymphoma, nasal type
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early-stage | — | UNRESOLVED | — |
| Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type | Nasal Type Extranodal NK/T-Cell Lymphoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-PD-1 monoclonal antibody | Drug | Anti-PD1 Monoclonal Antibody | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Inductive and concurrent anti-PD-1 antibody combined with radiotherapy
- description
- All the enrolled patients receive 2 doses of inductive anti-PD-1 antibody (Tislelizumab 200mg) every two weeks, and then Involved-site radiotherapy (50±6-10 Gy) with concurrent anti-PD-1 antibody (Tislelizumab 200mg) every two weeks.
- interventionNames
- Drug: Anti-PD-1 monoclonal antibody
Primary outcomes (1)
- measure
- Rate of Complete response after inductive therapy
- timeFrame
- 2-4 weeks after inductive anti-PD-1 antibody
- description
- complete resolution of disease in imaging and biopsy after inductive therapy
Secondary outcomes (5)
- measure
- Progression-free survival rate at year 2 after enrollment, 2y-PFS
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proved extranodal NK/T cell lymphoma * No previous anti-cancer treatment * Measurable lesion on baseline PET/CT and MRI * Stage I * Normal serum LDH level * Primary tumor invasion (PTI) absence * ECOG PS 0-1 * Sufficient organ functions Exclusion Criteria: * Other mature T- or NK- lymphoma * Hemophagocytic lymphohistiocytosis * Primary CNS lymphoma or CNS-involved lymphoma * History of malignancy except for cutaneous basal-/squamous- cell carcinoma or cervical carcinoma in situ 3 years prior to study treatment
References
Publications (1)
- DERIVEDLi JY, Qi SN, Hu C, Liu X, Yang Y, Wu T, Zheng R, Feng XL, Ni XG, Jin FY, Song YQ, Liu WP, Zhou SY, Li YX. Tislelizumab and radiation therapy in low-risk early-stage extranodal natural killer/T-cell lymphoma, nasal type: a phase II study protocol. Future Oncol. 2024 Feb;20(5):245-256. doi: 10.2217/fon-2023-0065. Epub 2023 Nov 29. PMID 38018460