Clinical trial · Interventional
Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent NPC
A Prospective, Single-arm, Multicenter Clinical Study of Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent Nasopharyngeal Carcinoma
NCT05350891CI-TRIAL-00058403unknownPhase 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)
A Prospective, Single-arm, Multicenter Clinical Study of Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent Nasopharyngeal Carcinoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| endoscopic surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- endoscopic surgery combined with adjuvant immunotherapy
- interventionNames
- Procedure: endoscopic surgery
Primary outcomes (1)
- measure
- progression free survival
- timeFrame
- From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first,through study completion,up to 2 years.
- description
- 2 year progression free survival
Secondary outcomes (1)
- measure
- Overall survival
- timeFrame
- From date of enrollment until the date of death from any cause,through study completion,up to 2 years.
- description
- 2 year Overall Survival rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathology or radiography confirmed recurrent nasopharyngeal carcinoma. * AJCC rT1-T4 which can be surgically removed. * Age ≥18 years old. * Informed consent signed. * With or without lymph node metastasis, which can be surgically removed. * No distant metastasis. * ≥6 months from the end of initial radiotherapy to recurrence. * Sufficient organ function a)Hematology: white blood cells ≥3.0 x 109/L, absolute neutrophil count ≥1.5x 109/L, hemoglobin ≥80 g/L, platelets ≥100 x 109/L. b) Liver function: bilirubin ≤ 1.5 times the upper limit of normal (ULN), AST and ALT ≤ 3 times the ULN c) International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN. d) Renal function: serum creatinine ≤ 1.5 times ULN. * ECOG score 0-2. general physical condition can tolerate general anesthesia surgery, chemotherapy, and immunotherapy. Exclusion Criteria: * Evidence of distant metastasis or leptomeningel disease (LMD). * Have received radioactive seed implantation in the treatment area. * Suffer from uncontrolled disease which could interfere with treatment. * Suffered from another malignant tumor or multiple primary tumors at the same time within 5 years (excluding fully treated basal cell or squamous cell skin cancer, cervical cancer in situ, etc.). * The patient has surgical contraindications: such as severe cardiopulmonary disease, coagulation dysfunction and so on. * The patients have autoimmune diseases. * The patient is using immunosuppressive agents or systemic glucocorticoid to achieve the purpose of immunosuppression (dose\>10mg/day prednisone or other), and continues to use it within 2 weeks before the first administration. * Severe allergic reaction to other monoclonal antibodies. * Previously received PD-1 monoclonal antibody, CTLA-4 monoclonal antibody (or any other antibody that acts on T cell co-stimulation or checkpoint pathway) treatment. * Live vaccines have been inoculated within 4 weeks before the first administration or during the study period. * The patient has any situation that may hinder study compliance or the safety during the study period. * Existence of serious neurological or psychiatric diseases, such as dementia and seizures. * Uncontrolled active infection. * Pregnant or breastfeeding women. * Those who have no personal freedom and independent capacity for civil conduct. * There are other situations that are not suitable for entry into the study.
References
Publications (0)
Data not yet available
No reference posted for this study.