Mucosal Melanoma of the Head and Neck
Conditions
Brief 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.
Interventions
DRUGneoadjuvant immunotherapy combing radiochemotherapy before Endoscopic Surgery
neoadjuvant immunotherapy(Toripalimab ) combine with radiotherapy and concurrent chemotherapy(Temozolomide) before Endoscopic Surgery
Sponsors
Eye & ENT Hospital of Fudan University
Huadong Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 (PT) or activated partial thromboplastin time (aPTT) ≤1.5 × ULN. Renal function: serum creatinine ≤1.5 × ULN. * Patients with recurrence after prior curative surgery are allowed; for recurrent patients, chemotherapy and immune therapy must have been discontinued for more than 6 months.
Exclusion criteria
* Patients who refuse to sign the informed consent form. * Patients with uncontrolled comorbidities that, in the investigator's judgment, would interfere with treatment. * Patients currently suffering from another malignant tumor or with synchronous multiple primary tumors that require treatment. * Patients with surgical contraindications, such as severe cardiopulmonary disease or coagulation disorders. * Patients with autoimmune diseases. * Patients currently using immunosuppressants, or receiving systemic glucocorticoids for immunosuppressive purposes (dose \>10 mg/day prednisone or equivalent), and who continue to use them within 2 weeks prior to first dosing. * Prior treatment with PD-1 monoclonal antibodies or PD-L1 monoclonal antibodies; or a history of severe allergic reactions to other monoclonal antibodies. * Receipt of a live vaccine within 6 weeks prior to first dosing, or the possibility of receiving a live vaccine during the study. * Any condition that may compromise protocol adherence or safety during the study. * Uncontrolled active infection. * Pregnant or breastfeeding women. * Any other condition deemed unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distant Metastasis-Free Survival (DMFS) | from sign informed consent to 24 months, assessed every 4-8week during treatment, 12 weeks in year 1 and every 24 weeks thereafter. | the time from sign informed consent to the first documentation of distant metastatic recurrence or death from any cause, whichever occurs first. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORHongmeng Yu
Eye & ENT Hospital,Fudan University
Outcome results
None listed