About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
neoadjuvant immunotherapy combing radiochemotherapy before Endoscopic Surgery
Drugneoadjuvant immunotherapy(Toripalimab ) combine with radiotherapy and concurrent chemotherapy(Temozolomide) before Endoscopic Surgery
Treatment groups
Trial outcomes
Primary outcomes
Distant Metastasis-Free Survival (DMFS)
the time from sign informed consent to the first documentation of distant metastatic recurrence or death from any cause, whichever occurs first.
Sponsors and contacts
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Eye & ENT Hospital of Fudan University
Lead sponsor
Huadong Hospital
Collaborator