Apatinib Plus SHR1210 in Advanced Mucosal Melanoma
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|ClinicalTrials.gov Identifier: NCT03986515|
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Mucosal Melanoma Advanced Cancer Apatinib SHR-1210||Drug: apatinib plus SHR-1210||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of SHR-1210 Plus Apatinib in Patients With Advanced Mucosal Melanoma Whose Diseases Progress After Chemotherapy|
|Actual Study Start Date :||June 4, 2019|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||May 31, 2022|
Experimental: treatment group
apatinib 250mg orally once a day until disease progression of occurrence of intolerable adverse events.
SHR-1210 200mg every two weeks until disease progression of occurrence of intolerable adverse events.
(the first dose of SHR-1210 is set on the 3-5 days after apatinib
Drug: apatinib plus SHR-1210
apatinib 250mg qd, 3-5 days later SHR-1210 200mg q3w
- objective response rate [ Time Frame: three months ]the proportion of patients with CR, PR, and SD in the group
- progression-free survival [ Time Frame: six months ]the time frame from the first day of apatinib to the date of confirmed progressive disease or death which one occurrs first.
- overall survival [ Time Frame: eighteen months ]the time frame from the first day of apatinib to the date of death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986515
|Contact: Lingdi Zhao, Dr.||+email@example.com|
|Contact: Yonghao Yang, Masterfirstname.lastname@example.org|
|Henan Cancer Hospital||Recruiting|
|Zhengzhou, Henan, China|
|Contact: Lingdi Zhao, Dr. +86-371-65587483 email@example.com|
|Principal Investigator:||Jing Ding, Master||Henan Cancer Hospital|