Overview

Phase II, single-arm, prospective clinical study of Toripalimab(a PD-1 antibody) combined with radiotherapy and chemotherapy in the treatment of sinonasal malignant mucosal melanoma after endoscopic surgery.

Eligibility

Inclusion Criteria:

        1.Pathologically diagnosed as sinonasal malignant mucosal melanoma, locally resectable and
        no contraindication for surgery or radiation. 2.T3 and T4. 3.Age ≥18 year-old 4.No distant
        metastasis 5.No head and neck radiation and systemic anti-tumor therapy performed in the
        past 5 years. 6.The performance status of the Eastern Cooperative Oncology Group(ECOG) is
        0-2 points and surgery after general anesthesia and postoperative radiation could be
        tolerated. 7.Accepted organ function
        Exclusion Criteria:
        1. Patients who refused to sign informed consent. 2. Have received radioactive seed
        implantation in the treatment area. 3. Suffer from uncontrolled disease which could
        interfere treatment. 4. Suffered from another malignant tumor or multiple primary tumors at
        the same time within 5 years (excluding fully treated basal cell or squamous cell skin
        cancer, cervical cancer in situ, etc.). 5. The patient has surgical contraindications: such
        as severe cardiopulmonary disease, coagulation dysfunction and so on. 6.The patients have
        autoimmune diseases. 7. The patient is using immunosuppressive agents or systemic hormone
        therapy to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other
        curative hormones), and continues to use it within 2 weeks before the first administration;
        8. Severe allergic reaction to other monoclonal antibodies; 9. Previously received PD-1
        monoclonal antibody, CTLA-4 monoclonal antibody (or any other antibody that acts on T cell
        co-stimulation or checkpoint pathway) treatment; 10. Live vaccines have been inoculated
        within 4 weeks before the first administration or during the study period; 11. The patient
        has any situation that may hinder study compliance or the safety during the study
        period.12. Existence of serious neurological or psychiatric diseases, such as dementia and
        seizures; 13. Uncontrolled active infection. 14. Pregnant or breastfeeding women. 15. Those
        who have no personal freedom and independent capacity for civil conduct;p. 16. There are
        other situations that are not suitable for entry into the study.