It is a RCT aimed to evaluate the Progression Free Survival of Camrelizumab combined with apatinib and temozolomide as First Line Therapy in Advanced Acral Melanoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
camrelizumab 200mg,q2w+apatinib 250mg,qd+TMZ 200mg/m2,day1-5/28
camrelizumab 200mg,q2w+apatinib 250mg qd
camrelizumab 200mg,q2w
Beijing Cancer Hospital
Beijing, China
RECRUITINGProgression Free Survival, PFS
PFS was defined as the time from randomization to progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first.
Time frame: Within 2 years
Overall Survival ,OS
OS will be defined as the time from randomization to death due to any cause.
Time frame: Within 2 years
ORR
The objective response rate will be assessed by RECIST 1.1
Time frame: Within 2 years
DCR
The disease control rate will be assessed by RECIST 1.1
Time frame: Within 2 years
Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment.
Time frame: Within 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.