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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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To determine the efficacy and Safety of intrapleural Bevacizumab and cisplatin as a treatment for malignant pleural effusions (MPE) in patients with non-small cell lung cancer (NSCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab & Cisplatin | Experimental | Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks |
|
| Cisplatin | Active Comparator | Cisplatin 30mg by intrapleural given every two weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab300mg&Cispltin30mg by intrapleural administration of each 2 week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With "Complete Response" and "Partial Response" | Response assessed by type-B ultrasonic tests; Complete remission (CR) was considered when the accumulated fluid had disappeared and was stable for at least four weeks; partial remission (PR) was considered when >50% of the accumulated fluid had disappeared, symptoms had improved, and the remaining fluid had failed to increase for at least four weeks; The total efficiency ORR was calculated by taking the sum of CR+PR | from randomization, This treatment was given every two weeks,responses were made by biweekly |
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression Free Survival (PFS) | baseline to biweekly,until disease progression | |
| Overall Survival (OS) | randomization to four weeks,until death | |
| Adverse Reactions |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative RT-PCR(Reverse Transcription-Polymerase Chain Reaction) for VEGF-A(Vascular Endothelial Growth Factor A) | before intrapleural administration |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nan Du | PLA 304 hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PLA 304 hospital | Beijing | Beijing Municipality | 100048 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab & Cisplatin | Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks Bevacizumab: Bevacizumab300mg&Cisplatin 30mg by intrapleural administration of each 2 week Cisplatin: Cisplatin 30mg,intrapleural administration,each 2 week |
| FG001 | Cisplatin | Cisplatin 30mg by intrapleural given every two weeks Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab & Cisplatin | Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks Bevacizumab: Bevacizumab300mg&Cisplatin 30mg by intrapleural administration of each 2 week Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W |
| BG001 | Cisplatin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With "Complete Response" and "Partial Response" | Response assessed by type-B ultrasonic tests; Complete remission (CR) was considered when the accumulated fluid had disappeared and was stable for at least four weeks; partial remission (PR) was considered when >50% of the accumulated fluid had disappeared, symptoms had improved, and the remaining fluid had failed to increase for at least four weeks; The total efficiency ORR was calculated by taking the sum of CR+PR | Posted | Number | participants | from randomization, This treatment was given every two weeks,responses were made by biweekly |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bevacizumab & Cisplatin | Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks Bevacizumab: Bevacizumab300mg&Cisplatin 30mg by intrapleural administration of each 2 week Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leucocytopenia | Blood and lymphatic system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nan Du | China PLA General Hospital | 86-13911599657 | dunan05@aliyun.com |
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| ID | Term |
|---|---|
| D016066 | Pleural Effusion, Malignant |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D010997 | Pleural Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Cisplatin | Drug | Cisplatin 30mg,intrapleural administration,each 2 week |
|
| Up to 1 month after the last treatment |
| Qualify of Life (QoL) | baseline to biweekly,until death |
Cisplatin 30mg by intrapleural given every two weeks Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Cisplatin |
Cisplatin 30mg by intrapleural given every two weeks Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W |
|
|
| Secondary | Median Progression Free Survival (PFS) | Not Posted | baseline to biweekly,until disease progression |
| Secondary | Overall Survival (OS) | Not Posted | randomization to four weeks,until death |
| Secondary | Adverse Reactions | Not Posted | Up to 1 month after the last treatment |
| Secondary | Qualify of Life (QoL) | Not Posted | baseline to biweekly,until death |
| Other Pre-specified | Quantitative RT-PCR(Reverse Transcription-Polymerase Chain Reaction) for VEGF-A(Vascular Endothelial Growth Factor A) | Not Posted | before intrapleural administration |
| 0 |
| 36 |
| 24 |
| 36 |
| EG001 | Cisplatin | Cisplatin 30mg by intrapleural given every two weeks Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W | 0 | 36 | 22 | 36 |
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| D009369 |
| Neoplasms |
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D008171 | Lung Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |