There is still no effective treatment for advanced mucosal melanoma at present. The efficacy of single-agent PD-1 inhibitors is less than 20%. It is urgent to explore regimens to improve the efficacy of PD-1 inhibitors in patients with advanced mucosal melanoma. This study is performed to explore the safety and efficacy of apatinib plus SHR-1210 in patients with advanced mucosa melanoma whose diseases progress after chemotherapy.
Apatinib is an oral small molecule anti-angiogenesis inhibitors. It inhibits VEGFR-2 tyrosine kinase activity, thereby blocking VEGF-induced signaling and exerting a strong inhibitory effect on tumor angiogenesis.Apatinib has shown anti-melanoma activity in retrospective study. However, the efficacy is still very low. SHR-1210 is an anti-PD-1 antibody produced by Hengrui Pharmaceutical Co., Ltd. Apatinib plus SHR-1210 has shown synergy in several malignancies. This study is conducted to explore the efficacy and safety in advanced mucosa melanoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
apatinib 250mg qd, 3-5 days later SHR-1210 200mg q3w
Henan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGobjective response rate
the proportion of patients with CR, PR, and SD in the group
Time frame: three months
progression-free survival
the time frame from the first day of apatinib to the date of confirmed progressive disease or death which one occurrs first.
Time frame: six months
overall survival
the time frame from the first day of apatinib to the date of death
Time frame: eighteen months
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