| Primary | IRC-assessed Progression-Free Survival (PFS) According to RECIST v1.1 | To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy as measured by IRC-assessed progression free survival (PFS) according to RECIST v1.1 in all patients. The definition of Progressive Disease: At least a 20% increasein the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. or the appearance of one or more new lesions is also considered progression. | | Posted | | Median | 95% Confidence Interval | months | | up to 2 years | | | | ID | Title | Description |
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| OG000 | Placebo Combine With Chemotherapy | Placebos: placebo combine with chemotherapy | | OG001 | TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy | TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0008.2(7.03 to 9.79)
- OG00121.4(11.73 to NA)Due to insufficient number of participants with events, the upper limit of the survival curve hasn't reached 50%, there is no estimate for the upper confidence limit on the median.
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| Secondary | OS | Overall survival was defined as the time from randomization to death from any cause. | NE below means "not estimable". | Posted | | Median | 95% Confidence Interval | months | | The time frame of OS collected is upto about 48months. | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Investigator-assessed ORR According to RECIST v1.1 | To evaluate the efficacy of TORIPALIMAB INJECTION(JS001) plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed overall response rate (ORR) according to RECIST v1.1. | | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Investigator-assessed DoR According to RECIST v1.1 | To evaluate the efficacy of TORIPALIMAB INJECTION(JS001 )plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed duration of response (DoR) according to RECIST v1.1. | | Posted | | Median | 95% Confidence Interval | months | | From date of response until progressive disease. Up to 2 approximately years | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Investigator-assessed DCR According to RECIST v1.1 | To evaluate the efficacy of TORIPALIMAB INJECTION(JS001) plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed disease control rate (DCR) according to RECIST v1.1. | | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Investigator-assessed PFS According to RECIST v1.1 | To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by Investigators-assessed PFS according to RECIST v1.1 | | Posted | | Median | 95% Confidence Interval | months | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Investigator-assessed PFS Rate at 1 Year | To evaluate the PFS rate at 1 year in each treatment arm by investigator | | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | up to approximately 1years | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| Secondary | OS Rate at 1 Year | To evaluate the OS rate at 1 year in each treatment arm | | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to approximately 1 years | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | IRC-assessed ORR According to RECIST v1.1 | health related quality of life (HRQoL) in patients treated with JS001 plus chemotherapy compared with placebo plus chemotherapy using the EORTC QLQ-H&N35 | | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | IRC-assessed DoR According to RECIST v1.1 | 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. | | Posted | | Median | 95% Confidence Interval | months | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | IRC-assessed DCR According to RECIST v1.1 | To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by IRC-assessed disease control rate (DCR) according to RECIST v1.1. | | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Number of Participants Experiencing an Adverse Event(AE) | Incidence of adverse events(AE) as assessed by CTCAE version 5.0 | | Posted | | Count of Participants | | Participants | | From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Anti-drug Antibody(ADA) | To evaluate the incidence of ADAs against JS001 | ADA testing only was applicable for Toripalimab group | Posted | | Count of Participants | | Participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | PFS IRC-assessed Per irRECIST | To evaluate PFS of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST. | | Posted | | Median | 95% Confidence Interval | months | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | ORR IRC-assessed Per irRECIST | To evaluate ORR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST. | | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | DoR IRC-assessed Per irRECIST | To evaluate DoR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST. | NE below means "not estimable" | Posted | | Median | 95% Confidence Interval | months | | From date of response until progressive disease. Up to 2 approximately years | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | DCR IRC-assessed Per irRECIST | To evaluate DCR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST. | | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | Investigator-assessed PFS Rate at 2 Years | To evaluate the PFS rate at 2 years in each treatment arm by investigator | | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | OS Rate at 2 Years | To evaluate the OS rate at 2 years in each treatment arm | | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to approximately 2 years | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | PFS Investigator-assessed Per irRECIST | To evaluate PFS of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST. | | Posted | | Median | 95% Confidence Interval | months | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | ORR Investigator-assessed Per irRECIST | To evaluate ORR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST. | | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | DoR Investigator-assessed Per irRECIST | To evaluate DoR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST. | | Posted | | Median | 95% Confidence Interval | months | | From date of response until progressive disease. Up to 2 approximately years | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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| Secondary | DCR Investigator-assessed Per irRECIST | To evaluate DCR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST. | | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to approximately 42 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
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