This study is a multicenter, single-arm, open, phase Ⅱ clinical study to evaluate the safety and efficacy of Toripalimab(JS001) monoclonal injection after chemotherapy in combination with Endostar for Locally Advanced or Metastatic Mucosal Melanoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Toripalimab, humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically. Toripalimab treatment after chemotherapy in combination with Endostar, 240 mg, Q3W, up to 2 years.
chemotherapy+ Endostar
Zhiguo Luo
Shanghai, Shanghai Municipality, China
RECRUITINGProgression-Free Survival, PFS
PFS is defined as the time from the date of first treatment to the first occurrence of disease progression or death from any cause.
Time frame: Approximately 1 years
Objective Response Rate, ORR
ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions \>= 4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
Time frame: Approximately 2 years
Overall Survival, OS
OS is defined as the time from the date of first treatment to death from any cause.
Time frame: Approximately 2 years
Incidence of AEs/SAEs
Percentage of Participants With Adverse Events/Severe Adverse Events
Time frame: Approximately 2 years
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