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This is a prospective phase II clinical study to assess the efficacy of Sintilimab combined with Bevacizumab for driving gene-negative, asymptomatic brain metastases from non-small cell lung cancer by intracranial ORR(iORR),also iPFS,ORR and PFS.The safety and tolerability is evaluated as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sintilimab and Bevacizumab | Experimental | Sintilimab 200mg d1 and Bevacizumab 15mg/kg d1 every 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sintilimab | Drug | Sintilimab 200mg d1 and Bevacizumab 15mg/kg d1 q21d |
|
| Measure | Description | Time Frame |
|---|---|---|
| iORR | intracranial objective response rate | 3.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| iPFS | intracranial progression free survival | 3.5 yesrs |
| ORR | objective response rate | 3.5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Likun Chen, doctor | Contact | 13798019964 | chenlk@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Likun Chen, doctor | Sun Yat-sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University of Cancer Center | Recruiting | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| PFS | progression free survival | 3.5 years |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |