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

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.

Study Overview

• Status: Recruiting
• Conditions: Mucosal Melanoma of the Head and Neck
• Intervention / Treatment: Drug: neoadjuvant immunotherapy combing radiochemotherapy before Endoscopic Surgery

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiaole Song; Phone Number: +64377134; Email: jxfxsxl@163.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200030
      • Recruiting
      • Eye & ENT Hospital
      • Sub-Investigator: Li Yan
      • Sub-Investigator: Xiaole Song
      • Contact: Xiaole Song; Phone Number: +86 64377134; Email: jxfxsxl@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: neoadjuvant immunotherapy combing radiochemotherapy before Endoscopic Surgery	Drug: neoadjuvant immunotherapy combing radiochemotherapy before Endoscopic Surgery; neoadjuvant immunotherapy(Toripalimab ) combine with radiotherapy and concurrent chemotherapy(Temozolomide) before Endoscopic Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University
• Collaborators: Huadong Hospital
• Investigators: Principal Investigator: Hongmeng Yu, Eye & ENT Hospital,Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: SNMM-Neo-V1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No