Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Three-drug arm | Experimental |
| |
| Two-drug arm | Active Comparator |
| |
| single-drug arm | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| camrelizumab+apatinib+TMZ | Drug | camrelizumab 200mg,q2w+apatinib 250mg,qd+TMZ 200mg/m2,day1-5/28 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival ,OS | OS will be defined as the time from randomization to death due to any cause. | Within 2 years |
| ORR | The objective response rate will be assessed by RECIST 1.1 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Guo, Dr | Contact | 010-88121122 | guoj307@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Guo, Dr | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | China |
Not provided
| ID | Term |
|---|---|
| C000631724 | camrelizumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| camrelizumab+apatinib | Drug | camrelizumab 200mg,q2w+apatinib 250mg qd |
|
| camrelizumab | Drug | camrelizumab 200mg,q2w |
|
| Within 2 years |
| DCR | The disease control rate will be assessed by RECIST 1.1 | 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. | Within 2 years |