30 patients with advanced melanoma will receive apatinib plus Temozolomide as maintenance therapy.
In this study, we plan to enroll 30 patients with advanced melanoma patients who have failed at least one systemic treatment regimen. The therapeutic regimen is temozolomide, 300mg,po, d1-5, apatinib, 500 mg, qd, po, d1-28, Every 28 days for 1 cycles, the primary end point was PFS, the secondary end point was OS, DCR, ORR etc. So we plan to investigate the safety and efficacy of apatinib combined with temozolomide in the treatment of advanced melanoma patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Apatinib:500mg/d,qd,po,d1-28
Temozolomide:300mg/d,qd,po,d1-5
Beijing Cancer Hospital
Beijing, China
RECRUITINGProgression Free Survival(PFS)
PFS is evaluated in 12 months since the treatment began
Time frame: 12 months
Objective Response Rate(ORR)
evaluated in the 12th month since the treatment began
Time frame: 12 months
Disease Control Rate(DCR)
evaluated in the 12th month since the treatment began
Time frame: 12 months
Overall Survival(OS)
evaluated in the 12th month since the treatment began
Time frame: 12 months
Safety and Tolerability as measured by adverse events
Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.03
Time frame: 12 months
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