This study is one monocentric, single-arm, open, phase Ⅱ clinical study to evaluate the safety and efficacy of Toripalimab monoclonal injection (Tuo Yi) combined with axitinib tablet (Inlyta®) as neoadjuvant therapy for localized mucosal melanoma. Primary objective: To evaluate pathological response (pCR+pPR) rate of Toripalimab combined with axitinib as neoadjuvant therapy for localized mucosal melanoma. The subjects will receive Toripalimab and Axitinib combined therapy after enrollment, and receive operation 2 weeks after the last dose of Axitinib. Toripalimab will be given for a total of 4 cycles (8 weeks), whereas Axitinib will be given for a total of 8 weeks.The subjects can receive Toripalimab for up to one year after the operation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
TORIPALIMAB INJECTION(JS001 ) combined with chemotherapy, 3mg/kg, Q2W,up to 1 years of treatment.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGPathological response (pCR+pPR) rate: defined as the percentage of subjects without alive tumor cells and alive tumor cells in postoperative resected specimens 10% - 50% in the resected specimen post operation.
To evaluate pathological response (pCR+pPR) rate of Toripalimab combined with axitinib as neoadjuvant therapy for localized mucosal melanoma.
Time frame: Approximately 8 weeks
RFS (recurrence-free survival) per RECIST1.1 as Assessed by investigator
To evaluate recurrence-free survival (RFS) of Toripalimab combined with axitinib as neoadjuvant therapy for localized mucosal melanoma.
Time frame: Approximately 1 years
OS (overall survival)
OS at 1 or 2 years.
Time frame: Approximately 2 years
Incidence of AEs/SAEs
Adverse events (AEs) ; serious adverse events (SAEs); abnormal value of Lab test according to NCI-CTCAE V5.0
Time frame: Approximately 2 years
Pathological complete response (pCR) rate: defined as the percentage of subjects without alive tumor cells in the resected specimen post operation.
To evaluate pathological complete response (pCR) rate of Toripalimab combined with axitinib as neoadjuvant therapy for localized mucosal melanoma.
Time frame: Approximately 8 weeks
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