NCT03581786 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- In the during-chemotherapy phase, placebo will be given before gemcitabine and cisplatin, placebo will be administered at the dose of 240 mg Q3W,gemcitabine 1000 mg/m² IV over 30 minutes are given on Days 1 \& 8, and cisplatin 80 mg/m² IV over 4 hours are given on Day 1 of each cycle. Chemotherapy is given Q3W for up to 6 cycles. During the post-chemotherapy phase, placebo and best supportive care (BSC) can be continued Q3W until excessive toxicity or progressive disease, withdrawal of consent, at the discretion of the Investigator or for a maximum of 2 years.
- id
- FG000
- title
- Placebo Combine With Chemotherapy
- description
- In the during-chemotherapy phase, JS001 will be given before gemcitabine and cisplatin, JS001 will be administered at the dose of 240 mg Q3W,gemcitabine 1000 mg/m² IV over 30 minutes are given on Days 1 \& 8, and cisplatin 80 mg/m² IV over 4 hours are given on Day 1 of each cycle. Chemotherapy is given Q3W for up to 6 cycles . During the post-chemotherapy phase, JS001 and best supportive care (BSC) can be continued Q3W until excessive toxicity or progressive disease, withdrawal of consent, at the discretion of the Investigator or for a maximum of 2 years.
- id
- FG001
- title
- TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 67
- group Id
- FG001
- num Subjects
- 47
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 5
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 7
- group Id
- FG001
- num Subjects
- 4
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- reason other than specified above
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 143
- group Id
- FG001
- num Subjects
- 146
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 67
- group Id
- FG001
- num Subjects
- 89
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 76
- group Id
- FG001
- num Subjects
- 57
- type
- NOT COMPLETED
- title
- Overall Study
Complete source fields
- groups
- description
- In the during-chemotherapy phase, placebo will be given before gemcitabine and cisplatin, placebo will be administered at the dose of 240 mg Q3W,gemcitabine 1000 mg/m² IV over 30 minutes are given on Days 1 \& 8, and cisplatin 80 mg/m² IV over 4 hours are given on Day 1 of each cycle. Chemotherapy is given Q3W for up to 6 cycles. During the post-chemotherapy phase, placebo and best supportive care (BSC) can be continued Q3W until excessive toxicity or progressive disease, withdrawal of consent, at the discretion of the Investigator or for a maximum of 2 years.
- id
- FG000
- title
- Placebo Combine With Chemotherapy
- description
- In the during-chemotherapy phase, JS001 will be given before gemcitabine and cisplatin, JS001 will be administered at the dose of 240 mg Q3W,gemcitabine 1000 mg/m² IV over 30 minutes are given on Days 1 \& 8, and cisplatin 80 mg/m² IV over 4 hours are given on Day 1 of each cycle. Chemotherapy is given Q3W for up to 6 cycles . During the post-chemotherapy phase, JS001 and best supportive care (BSC) can be continued Q3W until excessive toxicity or progressive disease, withdrawal of consent, at the discretion of the Investigator or for a maximum of 2 years.
- id
- FG001
- title
- TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 67
- group Id
- FG001
- num Subjects
- 47
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 5
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 7
- group Id
- FG001
- num Subjects
- 4
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- reason other than specified above
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 143
- group Id
- FG001
- num Subjects
- 146
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 67
- group Id
- FG001
- num Subjects
- 89
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 76
- group Id
- FG001
- num Subjects
- 57
- type
- NOT COMPLETED
- title
- Overall Study
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Preserved source evidence · Not medical advice
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