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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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This is a single arm, multi-center clinical trial. Target population is patients with Advanced or Metastatic Pulmonary Sarcomatoid Carcinoma,aiming to evaluate the efficacy and safety of the combination therapy of Camrelizumab and famitinib . Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody, and famitinib is an orally bioavailable receptor tyrosine kinase (RTK) inhibitor.
This trial enrolled patients with advanced or metastatic pulmonary sarcomatoid carcinoma. Patients will receive camrelizumab 200 mg every 3 weeks and famitinib 20 mg once per day. The primary endpoint is objective response rate (ORR) assessed by investigators per RECIST version 1.1. Key secondary endpoints were progression-free survival (PFS), overall survival (OS), duration of response, and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab + Famitinib | Experimental | Patients received camrelizumab 200 mg every 3 weeks and famitinib 20 mg once per day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Patients received camrelizumab 200 mg every 3 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Objective Response Rate using RECIST 1.1 criteria, Proportion of patients with CR and PR | about 24 month |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Time from the date of first dose to first observation of progression (RECIST1.1) or date of death (from any cause) | about 24 month |
| Overall Survival | Time from the date of first dose to death from any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Chu | Contact | 13212760751 | +86 | qianchu@163.com |
| Lin Wu | Contact | 13170419973 | +86 | wulin-calf@vip.163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qian Chu | Tongji Hospital | Principal Investigator |
| Lin Wu | Hunan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first Affiliated Hospital of Xiamen University | Active, not recruiting | Xiamen | Fujian | China | ||
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C584390 | famitinib |
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| Famitinib | Drug | Patients received Famitinib 20 mg once per day |
|
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| about 24 month |
| Duration of response | Time from the date of the first documented response (CR or PR) to the earliest date of disease progression (RECIST 1.1), or death due to any cause. | about 24 month |
| incidence, type and severity of adverse events | Descriptive statistics of safety will be presented using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 | From time of informed consent through treatment period and up to 30 days post last dose of study treatment (about 24 months) |
| Disease control rate | Disease control rate using RECIST 1.1 criteria, Proportion of patients with CR, PR and SD | about 24 month |
| Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University |
| Recruiting |
| Zhengzhou |
| Henan |
| China |
|
| Henan Provincial People's Hospital | Recruiting | Zhengzhou | Henan | China |
|
| Qian Chu | Recruiting | Wuhan | Hubei | 430000 | China |
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| Hubei Cancer Hospital | Recruiting | Wuhan | Hubei | China |
|
| Renmin Hospital of Wuhan University Hubei General Hospital | Recruiting | Wuhan | Hubei | China |
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| The Second Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | China |
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| The First Affiliated Hospital of Shandong First Medical University | Active, not recruiting | Jinan | Shandong | China |