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| Name | Class |
|---|---|
| Zhejiang Cancer Hospital | OTHER |
| Fujian Cancer Hospital | OTHER_GOV |
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
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This study is a multicenter, single-arm, open, phase â…¡ clinical study to evaluate the safety and efficacy of Toripalimab(JS001) monoclonal injection after chemotherapy in combination with Endostar for Locally Advanced or Metastatic Mucosal Melanoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chemotherapy+Endostar+Toripalimab(JS001) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toripalimab | Drug | Toripalimab, humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically. Toripalimab treatment after chemotherapy in combination with Endostar, 240 mg, Q3W, up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival, PFS | PFS is defined as the time from the date of first treatment to the first occurrence of disease progression or death from any cause. | Approximately 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate, ORR | ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions >= 4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). | Approximately 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhiguo Luo | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
| D004358 | Drug Therapy |
| C522911 | endostar protein |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
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| chemotherapy in combination with Endostar | Drug | chemotherapy+ Endostar |
|
| Overall Survival, OS |
OS is defined as the time from the date of first treatment to death from any cause. |
| Approximately 2 years |
| Incidence of AEs/SAEs | Percentage of Participants With Adverse Events/Severe Adverse Events | Approximately 2 years |