Exploratory Clinical Study of Neoadjuvant Immunotherapy Combined With Chemotherapy in Mali
Sinonasal mucosal malignant melanoma (SNMM) is a nasal and paranasal sinus malignancy with a low incidence and extremely poor prognosis, exhibiting specificity in Asian populations. For resectable SNMM, the efficacy of neoadjuvant immunotherapy is unclear. This prospective clinical study aims to explore the survival pr
| Condition(s) | Mucosal Melanoma of the Head and Neck |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | Sinonasal mucosal malignant melanoma (SNMM) is a nasal and paranasal sinus malignancy with a low incidence and extremely poor prognosis, exhibiting specificity in Asian populations. For resectable SNMM, the efficacy of neoadjuvant immunotherapy is unclear. This prospective clinical study aims to explore the survival prognosis of neoadjuvant immunotherapy combing radiochemotherapy after Endoscopic Surgery for resectable SNMM. |
| Who can participate | Inclusion Criteria: * Histopathologically confirmed diagnosis of malignant melanoma of the nasal cavity and paranasal sinuses. * T stage of T3 or T4a. * Age ≥18 years. * No distant metastasis. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, with general condition tolerating chemotherapy and general anesthesia for surgery. * Locally resectable with curative intent, and able to undergo contrast-enhanced CT or contrast-enhanced MRI examinations. * Adequate organ function: Hematology: white blood cells ≥3.0 × 10\^9/L; absolute neutrophil count ≥1.5 × 10\^9/L; hemoglobin ≥80 g/L; platelets ≥100 × 10\^9/L. Hepatic function: total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤3 × ULN. Coagulation: international normalized ratio (INR) or prothrombin time |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Eye & ENT Hospital of Fudan University |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2023-06-01 |
| NCT ID | NCT07614828 |
| Official listing | https://clinicaltrials.gov/study/NCT07614828 |