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Mucosal melanoma (MM) is a highly angiolyculated tumor with a very poor prognosis.
the study is an open-label, randomized Phase II trial designed to assess the efficacy and safety of beval's monoantigenated carbide and yew alcohol (CPB) for previously treated late-stage MMs.
the subjects were randomly divided into two groups at 2:1 and treated with carptonin-yew alcohol-beval monoantigen (CPB) or carptonin-yew alcohol (CP).
end point is progress-free survival (PFS).
end points include overall survival (OS), objective mitigation rates, and side-reaction events.
114 patients were recruited, and the mid-PFS in the CPB group was significantly longer than in the CP group: 4.8 months (95% CI 3.6-6.0) vs 3.0 months (3.0 months) 1.7-4.3; Risk ratio of 0.461,95% CI 0.306-0.695, p.lt;0.001).
OS in the CCP group is also clearer than the CP group: 13.6 vs. 9.0 months (HR 0.611, 95% CI 0.407-0.917, p=0.017).
the objective mitigation rates of the CCP group and the CP group were 19.7% and 13.2%, respectively.
no new security issues have been observed.
, metastasis MM patients treated with beva monoantigenated carbide and yew alcohol were better at PFS and OS than those treated with carblatin-only combined yew alcohol alone.
should be carried out in phase 3 trials to further verify the efficacy of the program.
