A mucosal melanoma postoperative adjuvant treatment of multicenter, randomized, double-blind, placebo-controlled phase II study, evaluation of mucosal melanoma patients accept completely resected, Toripalima Combined with Temozolomide and Cisplatin postoperative adjuvant therapy efficacy and safety
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
294
Injection,Specification 240mg/6ml, 3 mg/kg for the dose, iV, every 2 weeks a dose cycle, up to 1 year; Temozolomide: 100mg or 20mg, Every 4 weeks a dose cycle, up to 6 cycles Cisplatin: Injection, 20mg,Every 4 weeks a dose cycle, up to 6 cycles
Placebo:Injection,Specification 240mg/6ml, 3 mg/kg for the dose, iV, every 2 weeks a dose cycle, up to 1 year; Temozolomide: 100mg or 20mg, Every 4 weeks a dose cycle, up to 6 cycles Cisplatin: Injection, 20mg,Every 4 weeks a dose cycle, up to 6 cycles
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGRFS assessment per RECIST 1.1.
To Compare the recurrence free survival (RFS) per response evaluation crieria in solid tumors(RECIST 1.1) in subjects of the postoperative adjuvant treatment of completely resected mucosal melanoma treated between Toripalima combined with Temozolomide and Cisplatin and placebo combined with Temozolomideand Cisplatin .
Time frame: 2 years
RFS assessment per RECIST1.1 in 1 year and 2 year;
1 year and 2 year recurrence free survival rate of completely resected mucosal melanoma with postoperative adjuvant treatment, will be assessed using RECIST1.1 to evaluate tumor recurrence.
Time frame: 2 years
DMFS assessed by investigator per RECIT1.1;
Distant metastasis free survival (DMFS) of completely resected mucosal melanoma with postoperative adjuvant treatment per RECIST 1.1;
Time frame: 2 years
Overall survival (OS) per death time;
Overall survival (OS) of completely resected mucosal melanoma with postoperative adjuvant treatment per death time;
Time frame: 2 years
.Incidence and grade of AEs and SAEs related to study drugs per NCI-CTCAE version 5.0, AEs ≥ grade 3 related to the study drugs.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 for safty evaluation.
Time frame: 2 years
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