Clinical trial · Interventional
PD-1 Combined With Intensity Modulated Radiation Therapy in the Treatment of Intermediate-risk Nasopharyngeal Carcinoma
PD-1 Immune Checkpoint Inhibitor Combined With Intensity Modulated Radiation Therapy in the Treatment of Intermediate-risk Nasopharyngeal Carcinoma (T2-3N0 or T1-2N1 and EBV-DNA≤4000 Copy/ml),A Single-arm, Phase II Clinical Trial
NCT05229315CI-TRIAL-00065600unknownPhase 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)
To evaluate the safety and efficacy of PD-1 immune checkpoint inhibitor combined with intensity modulated radiation therapy in the treatment of intermediate-risk nasopharyngeal carcinoma (T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml).
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 |
|---|---|---|---|
| EBV-DNA≤4000 Copy/ml | — | UNRESOLVED | — |
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| T2-3N0 or T1-2N1 | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensity modulated radiotherapy | Procedure | — | UNRESOLVED |
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PD-1 Immune Checkpoint Inhibitor Combined With Intensity Modulated Radiation Therapy
- description
- Intensity modulated radiation therapy combined with toripalimab in the treatment of nasopharyngeal carcinoma,once every 2 weeks, 10 cycles in total
- interventionNames
- Drug: Toripalimab
- Procedure: Intensity modulated radiotherapy
Primary outcomes (1)
- measure
- Adverse events
- timeFrame
- Recent evaluation: 3 months after the end of treatment;Long-term follow-up: 1~5 years after the end of treatment
- description
- The severity of adverse events will be determined by the investigator based on CTCAE v 5.0
Secondary outcomes (4)
- measure
- overall survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed patients who have not received radiotherapy or chemotherapy * Pathologically diagnosed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, WHO classification type II or type III). * T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml (AJCC 8th version) and EBV-DNA≤4000copies/ml * Male or non-pregnant female * Age between 18 and 65 * Eastern Cooperative Oncology Group(ECOG)score of 0-1. * Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109/L, platelet (PLT) ≥100×109/L. * Liver function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST) \<2.0 times the upper limit of normal (ULN); total bilirubin \<2.0×ULN. * Renal function: creatinine clearance rate ≥60ml/min or serum creatinine \<1.5×ULN. * The patient has signed the informed consent Exclusion Criteria: * The pathology is keratinizing squamous cell carcinoma (WHO classification is type I). * Patients with recurrence and distant metastasis. * Patients who have undergone radiotherapy or chemotherapy. * Active hepatitis B (HBV-DNA≥500). * Patients with autoimmune diseases. * Patients with HIV infection. * At the same time suffering from other uncontrolled serious diseases. * Persons with abnormal functions of the heart, brain, lungs and other important organs. * Age\> 65 years. * pregnancy or breast feeding. * Persons with personality or mental illness, without or with limited capacity for civil conduct
References
Publications (0)
Data not yet available
No reference posted for this study.