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There is still no effective treatment for advanced mucosal melanoma at present. The efficacy of single-agent PD-1 inhibitors is less than 20%. It is urgent to explore regimens to improve the efficacy of PD-1 inhibitors in patients with advanced mucosal melanoma. This study is performed to explore the safety and efficacy of apatinib plus SHR-1210 in patients with advanced mucosa melanoma whose diseases progress after chemotherapy.
Apatinib is an oral small molecule anti-angiogenesis inhibitors. It inhibits VEGFR-2 tyrosine kinase activity, thereby blocking VEGF-induced signaling and exerting a strong inhibitory effect on tumor angiogenesis.Apatinib has shown anti-melanoma activity in retrospective study. However, the efficacy is still very low. SHR-1210 is an anti-PD-1 antibody produced by Hengrui Pharmaceutical Co., Ltd. Apatinib plus SHR-1210 has shown synergy in several malignancies. This study is conducted to explore the efficacy and safety in advanced mucosa melanoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| apatinib plus SHR-1210 | Drug | apatinib 250mg qd, 3-5 days later SHR-1210 200mg q3w |
|
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate | the proportion of patients with CR, PR, and SD in the group | three months |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | the time frame from the first day of apatinib to the date of confirmed progressive disease or death which one occurrs first. | six months |
| overall survival | the time frame from the first day of apatinib to the date of death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lingdi Zhao, Dr. | Contact | +86-371-65587483 | lingdizhao@126.com | |
| Yonghao Yang, Master | Contact | +86-371-65587483 | 215582454@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Ding, Master | Henan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42093981 | Derived | Zhang Y, Wang T, Lyu AQ, Zhang F, Li FH, Zhao LD, Wang ZB, Shang YM, Ma BZ, Dong XQ, Gao QL. Real-world study of SHR-1210 plus apatinib in the treatment of BRAF-negative mucosal melanoma: efficacy, safety and implications of precision medicine. Front Immunol. 2026 Apr 21;17:1755669. doi: 10.3389/fimmu.2026.1755669. eCollection 2026. |
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| ID | Term |
|---|---|
| C553458 | apatinib |
| C000631724 | camrelizumab |
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| eighteen months |