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This study is to explore the treatment of advanced sarcomatoid carcinoma or Carcinosarcoma with Carrelizumab combined with Apatinib, in order to provide guidance and experience for new combined therapy in clinic.
A number of clinical studies have shown that PD-1 immunotherapy combined with anti-vascular target drugs has achieved good clinical efficacy in primary liver cancer, nasopharyngeal carcinoma, esophageal cancer and other tumors. For sarcomatoid carcinoma, which is a rare tumor with large heterogeneity, poor treatment effect and poor prognosis, clinicians are facing great confusion on how to find a good treatment regimen in clinic. The purpose of this study is to explore the treatment of advanced sarcomatoid carcinoma with PD-1 antibody Camrelizumab combined with anti-vascular target drug Apatinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab Combined With Apatinib | Experimental | Apatinib tablets: 250mg qd.po, 4 weeks as a cycle, continuous medication until disease progression, death or intolerable toxicity; Camrelizumab: administered intravenously with a fixed dose of 200mg, administered intravenously (without preventive medication), each infusion for 30min (no less than 20min, no more than 60min), administered once every two weeks until disease progression, death or intolerable toxicity. The maximum period is 2 years. The curative effect was evaluated every 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab Combined With Apatinib | Drug | After signing the informed consent, the selected patients received Camrelizumab combined with Apatinib. Treatment until disease progression and intolerable adverse reactions occur |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | objective response rate | the rate of patients with CR and PR, through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| OS | overall survival | from the time signing of ICF until the date of death from any cause, assessed up to 36 months |
| PFS | progression free survival |
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Inclusion Criteria:
Exclusion criteria
Those who have one or more of the following are not eligible for this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaowei Zhang, Doctor | Contact | 021-64175590 | 88503 | dongfangzhizizhxw@aliyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D002296 | Carcinosarcoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018193 | Neoplasms, Complex and Mixed |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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Regimen: Apatinib: 250mg qd, po, 4 weeks as a cycle, continuous medication until disease progression, death or intolerable toxicity; Carrelizumab: administered intravenously with a fixed dose of 200mg, administered intravenously (without preventive medication), each infusion for 30min (no less than 20min, no more than 60min), administered once every two weeks until disease progression, death or intolerable toxicity. The maximum period is 2 years.
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| from the time signing of ICF until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months |
| AE | the adverse events of all enrolled patients | the adverse events rate and types of all enrolled patients, through study completion, an average of 1 year |
| DCR | disease control rate | the rate of patients with CR, PR and SD, through study completion, an average of 1 year |
| D012509 | Sarcoma |
| D018204 | Neoplasms, Connective and Soft Tissue |