Clinical trial · Interventional
A Study of Tislelizumab, Chemotherapy, and Radiation Therapy for Early-Stage High-Risk ENKTCL (CLCG-2102)
Tislelizumab Plus Dose-Dense P-GemOx and Radiation Therapy for Early-Stage Intermediate/High-Risk Extranodal NK/T-Cell Lymphoma: A Multicenter Phase II Trial
NCT05254899CI-TRIAL-00123000CLCG-2102completedPhase 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 inductive Anti-PD-1+P-GEMOX treatment followed by radiotherapy and concurrent Anti-PD-1 antibody in early-stage Intermediate/High-Risk extranodal NK/T cell lymphoma
Conditions
Conditions (3)
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 Type Extranodal NK/T-Cell Lymphoma | ALIAS | 0.90 |
| High-Risk Cancer | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-PD-1 monoclonal antibody | Drug | Anti-PD1 Monoclonal Antibody | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Involved site radiotherapy | Radiation | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Pegaspargase | Drug | Pegaspargase | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Inductive and concurrent anti-PD-1 antibody combined with chemo-radiotherapy
- description
- All the enrolled patients receive 3 cycles of anti-PD-1 antibody (Tislelizumab 200mg d1) + P-GEMOX (Pegaspargase 3000u d2, Gemcitabine 1g/m2 d2, Oxaliplatin 85mg/m2 d2) systemic treatment every 14 days, followed by involved-site radiotherapy with concurrent anti-PD-1 antibody (Tislelizumab 200mg) every two weeks.
- interventionNames
- Drug: Anti-PD-1 monoclonal antibody
- Drug: Pegaspargase
- Drug: Gemcitabine
- Drug: Oxaliplatin
- Radiation: Involved site radiotherapy
Primary outcomes (1)
- measure
- Complete Response rate after 3 cycles of Anti-PD-1 antibody and P-GEMOX therapy
- timeFrame
- At the end of Cycle 3 (each cycle is 14 days)
- description
- To evaluate the complete response (CR) rate after 3 cycles of Anti-PD-1 antibody and P-GEMOX therapy according to Lyric 2016 criteria
Secondary outcomes (5)
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-II * Have at lest one following risk factor: Elevated serum LDH level; PTI+; stage II * 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 (0)
Data not yet available
No reference posted for this study.