The Efficacy and Safety of Neoadjuvant Toripalimab Combined With Temozolomide in Resectable Stage III Melanoma

Inclusion Criteria: Has resectable stage IIIB-IIID melanoma of acral and cutaneous type, according to American Joint Committee on Cancer (AJCC) staging system version 8. At least one measurable lesion conforming to RECIST 1.1 criteria. No previously received systematic therapy of anti-PD-1 plus temozolomide. For patients with relapsed melanoma, previous therapy of anti-PD-1 plus temozolomide has been stopped for more than 6 months is acceptable. For patients with disease progressed after receiving immune checkpoint inhibitors only, time from the last treating day is ≥ 4 weeks. The toxicity of prior treatment has recovered to ≤1 grade according to CTCAE 5.0. ECOG score 0-1. The expected survival time is ≥ 12 weeks. Adequate organ and bone marrow function. Female subjects of childbearing age must undergo a serum pregnancy test within 7 days before the commencement of the study and the results are negative, and are willing to use a medically approved high potency contraceptive method during the study period and within 3 months after the last administration of the study drug; For male subjects whose partner is a female of childbearing age, they should be surgically sterilized or agree to use an effective method of contraception during the study period and for 3 months after administration of the last study. Willing to consent and signed the informed consent, and able comply with the planned visit, research treatment, laboratory examination and other test procedures. Exclusion Criteria: Has mucosal melanoma or choroidal melanoma. The first study drug treatment was less than 4 weeks from the last systematic antitumor therapy or 5 half-lives from the last targeted therapy; less than 4 weeks from major surgery; less than7 days from immunosuppressive drug; less than 3 weeks from immunomodulatory; less than 4 weeks from live attenuated vaccine. Systemic antibiotic use for 7 days within 4 weeks prior to initial administration, or unexplained fever during screening/prior to initial administration. With active autoimmune disease or a history of autoimmune disease. With history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. With immunodeficiency, eg HIV, HBV, HCV. Have a clear history of serious and uncontrolled other disease or mental disorders. Has a bleeding tendency or abnormal clotting function. Known to be allergic to the active ingredients or excipients in this study. Other situations that the researcher considers inappropriate to participate in the research.