Neoadjuvant SHR-1701 Plus Famitinib With Response-guided Adjuvant Therapy in Resectable Mucosal Melanoma

A Multicenter, Phase II Clinical Trial of Neoadjuvant SHR-1701 Plus Famitinib With Response-guided Adjuvant Therapy in Resectable Mucosal Melanoma (The ASPRIE-MM Study)

This study aims to investigate the efficacy and safety of SHR-1701 in combination with famitinib in the perioperative treatment of mucosal melanoma

Inclusion Criteria:

• Age ≥ 18 years and ≤ 75 years, regardless of sex.
• Histopathologically confirmed mucosal melanoma.
• Focal, lymph node metastatic, or oligometastatic mucosal melanoma assessed as completely resectable by multidisciplinary team (surgery/ENT/gynecology/colorectal, radiotherapy, oncology, imaging/pathology, etc.).
• ECOG Performance Status of 0 or 1.
• Life expectancy ≥ 12 weeks.

Exclusion Criteria:

• Prior treatment with PD-1/PD-L1 antibodies or anti-angiogenic agents.
• Ocular melanoma or melanoma of unknown primary site.
• History of immunodeficiency, acquired or congenital immune deficiency diseases, or organ transplantation.
• Pregnant or breastfeeding women.
• Abnormal coagulation function (APTT > 43 seconds or INR > 1.5 × ULN), or history of bleeding tendency or bleeding events (e.g., gastrointestinal bleeding, gastric ulcer bleeding) within 3 months before enrollment.