Exploratory Clinical Study of Neoadjuvant Immunotherapy Combined With Chemotherapy in Malignant Melanoma of Nasal and Paranasal Mucosa
Eye & ENT Hospital of Fudan University
25 participants
Jun 1, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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 Criteria12
- 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.
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Interventions
neoadjuvant immunotherapy(Toripalimab ) combine with radiotherapy and concurrent chemotherapy(Temozolomide) before Endoscopic Surgery
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07614828