TriangleNCT03581786 · OUTCOME
IRC-assessed DoR According to RECIST v1.1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
What was measured
To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by IRC-assessed duration of response (DoR) according to RECIST v1.1.
Groups in this outcome
Placebo Combine With Chemotherapy
Gemcitabine 1000 mg/m² IV are given on Days 1 \& 8, and cisplatin 80 mg/m² IV are given on Day 1 of each cycle，placebo will be administered at the dose of 240 mg Q3W before that. Chemotherapy is given Q3W for up to 6 cycles and placebo for up to 2 years
TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy
Gemcitabine 1000 mg/m² IV are given on Days 1 \& 8, and cisplatin 80 mg/m² IV are given on Day 1 of each cycle，JS001 will be administered at the dose of 240 mg Q3W before that. Chemotherapy is given Q3W for up to 6 cycles and JS001 for up to2years
| Group | Source count |
|---|---|
| Placebo Combine With Chemotherapy | 96 |
| TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | 115 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo Combine With Chemotherapy | 6.0 | Not reported | 5.55 | 8.25 | Not reported |
| TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | 18.0 | Not reported | 10.51 | NA | Due to insufficient number of participants with events, the upper limit of the survival curve has not reached 50%, there is no estimate for the upper confidence limit on the median. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.55
- upper Limit
- 8.25
- value
- 6.0
- comment
- Due to insufficient number of participants with events, the upper limit of the survival curve has not reached 50%, there is no estimate for the upper confidence limit on the median.
- group Id
- OG001
- lower Limit
- 10.51
- upper Limit
- NA
- value
- 18.0
- denoms
- counts
- group Id
- OG000
- value
- 96
- group Id
- OG001
- value
- 115
- units
- Participants
- description
- To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by IRC-assessed duration of response (DoR) according to RECIST v1.1.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Gemcitabine 1000 mg/m² IV are given on Days 1 \& 8, and cisplatin 80 mg/m² IV are given on Day 1 of each cycle，placebo will be administered at the dose of 240 mg Q3W before that. Chemotherapy is given Q3W for up to 6 cycles and placebo for up to 2 years
- id
- OG000
- title
- Placebo Combine With Chemotherapy
- description
- Gemcitabine 1000 mg/m² IV are given on Days 1 \& 8, and cisplatin 80 mg/m² IV are given on Day 1 of each cycle，JS001 will be administered at the dose of 240 mg Q3W before that. Chemotherapy is given Q3W for up to 6 cycles and JS001 for up to2years
- id
- OG001
- title
- TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
- title
- IRC-assessed DoR According to RECIST v1.1
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice