Exploratory Clinical Study of Neoadjuvant Immunotherapy Combined With Chemotherapy in Malignant Melanoma of Nasal and Paranasal Mucosa

NCT07614828 | Recruiting Phase 2

• 1 other identifier: SNMM-Neo-V1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Mucosal Melanoma of the Head and Neck

Outcome Measures

Primary Outcomes (1)

• 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.

  from sign informed consent to 24 months, assessed every 4-8week during treatment, 12 weeks in year 1 and every 24 weeks thereafter.

Study Arms (1)

neoadjuvant immunotherapy combing radiochemotherapy before Endoscopic Surgery

EXPERIMENTAL

Drug: neoadjuvant immunotherapy combing radiochemotherapy before Endoscopic Surgery

Interventions

neoadjuvant immunotherapy combing radiochemotherapy before Endoscopic Surgery DRUG

neoadjuvant immunotherapy(Toripalimab ) combine with radiotherapy and concurrent chemotherapy(Temozolomide) before Endoscopic Surgery

neoadjuvant immunotherapy combing radiochemotherapy before Endoscopic Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead
• Huadong Hospital: collaborator

Study Sites (1)

Eye & ENT Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Study Officials

• Hongmeng Yu

  Eye & ENT Hospital,Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaole Song

CONTACT

+64377134; jxfxsxl@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Eye & ENT Hospital of Fudan University

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 29, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (1)