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.
age:≥18 years, male or female.
Histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage III/IV).
Has not received any systematic anti-tumor drug treatment.
Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
Known history of hypersensitivity to macromolecular protein preparation or any components of the drug formulation.
Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
Subjects with any active autoimmune disease or history of autoimmune disease Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
Parallel
camrelizumab+apatinib+TMZ
Drugcamrelizumab 200mg，q2w+apatinib 250mg，qd+TMZ 200mg/m2，day1-5/28
camrelizumab+apatinib
Drugcamrelizumab 200mg，q2w+apatinib 250mg qd
camrelizumab
Drugcamrelizumab 200mg，q2w
Progression 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.
Overall Survival ,OS
OS will be defined as the time from randomization to death due to any cause.
ORR
The objective response rate will be assessed by RECIST 1.1
DCR
The disease control rate will be assessed by RECIST 1.1
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.
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