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| Name | Class |
|---|---|
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
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To explore the dose and safety of thalidomide for the prevention and treatment of camrelizumab-induced reactive cutaneous capillary endothelial proliferation (RCCEP)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevention Cohort 1 Group A | Experimental | Camrelizumab + chemotherapy+Thalidomide(50mg) |
|
| Prevention Cohort 1 Group B | Experimental | Camrelizumab + chemotherapy+Thalidomide(100mg) |
|
| Treatment Cohort 2 Group A | Experimental | Thalidomide(100mg) |
|
| Treatment Cohort 2 Group B | Experimental | Thalidomide(200mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab 200mg intravenous (IV) on Day 1 of each 21-day cycle,until progression or unacceptable toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of RCCEP | Incidence rate of RCCEP | 2 years |
| RCCEP response rate at 3 weeks | RCCEP response rate at 3 weeks | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of ≥G3 grade RCCEP | Incidence rate of ≥G3 grade RCCEP | 2 years |
| Median time to RCCEP | Median time to RCCEP | 2 years |
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Inclusion Criteria:
Prevention cohort 1:
Treatment cohort 2:
Exclusion Criteria:
Prevention cohort 1:
Treatment cohort 2:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Liu, MD | Contact | +86 137 8360 4602 | yaya7207@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying Liu, MD | Henan Cancer Hospital | Principal Investigator |
| Yu Yao, MD | First Affiliated Hospital Xi'an Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ying Liu | Recruiting | Zhengzhou | Henan | China |
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|
| Thalidomide 50mg | Drug | Thalidomide 50mg,po qd; |
|
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| Thalidomide 100mg | Drug | Thalidomide 100mg,po qd; |
|
|
| Thalidomide 200mg | Drug | Thalidomide 200mg,po qd; |
|
|
| Chemotherapy | Drug | Platinum-based chemotherapy:
|
|
|
| Incidence rate of RCCEP at 6 weeks | Incidence rate of RCCEP at 6 weeks | 6 weeks |
| Incidence rate of RCCEP at 9 weeks | Incidence rate of RCCEP at 9 weeks | 9 weeks |
| Median time to response of RCCEP | Median time to response of RCCEP | 2 years |
| Thalidomide treatment-related adverse events | Thalidomide treatment-related adverse events | 2 years |
| The First Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi'an | Shaanxi | China |
|
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D013792 | Thalidomide |
| D004358 | Drug Therapy |
| D017671 | Platinum Compounds |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013812 | Therapeutics |
| D007287 | Inorganic Chemicals |
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