Trial · NCT03581786
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | IRC-assessed Progression-Free Survival (PFS) According to RECIST v1.1 | up to 2 years | 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. |
| Secondary | OS | The time frame of OS collected is upto about 48months. | Overall survival was defined as the time from randomization to death from any cause. |
| Secondary | Investigator-assessed ORR According to RECIST v1.1 | 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 | 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. |
| Secondary | Investigator-assessed DoR According to RECIST v1.1 | From date of response until progressive disease. Up to 2 approximately years | 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. |
| Secondary | Investigator-assessed DCR According to RECIST v1.1 | 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 | 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. |
| Secondary | Investigator-assessed PFS According to RECIST v1.1 | 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 | To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by Investigators-assessed PFS according to RECIST v1.1 |
| Secondary | Investigator-assessed PFS Rate at 1 Year | up to approximately 1years | To evaluate the PFS rate at 1 year in each treatment arm by investigator |
| Secondary | OS Rate at 1 Year | Up to approximately 1 years | To evaluate the OS rate at 1 year in each treatment arm |
| Secondary | IRC-assessed ORR According to RECIST v1.1 | 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 | health related quality of life (HRQoL) in patients treated with JS001 plus chemotherapy compared with placebo plus chemotherapy using the EORTC QLQ-H\&N35 |
| Secondary | IRC-assessed DoR According to RECIST v1.1 | 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 | 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. |
| Secondary | IRC-assessed DCR According to RECIST v1.1 | From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years | 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. |
| Secondary | Number of Participants Experiencing an Adverse Event(AE) | From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years | Incidence of adverse events(AE) as assessed by CTCAE version 5.0 |
| Secondary | Anti-drug Antibody(ADA) | 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 | To evaluate the incidence of ADAs against JS001 |
| Secondary | PFS IRC-assessed Per irRECIST | 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 | To evaluate PFS of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST. |
| Secondary | ORR IRC-assessed Per irRECIST | 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 | To evaluate ORR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST. |
| Secondary | DoR IRC-assessed Per irRECIST | From date of response until progressive disease. Up to 2 approximately years | To evaluate DoR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST. |
| Secondary | DCR IRC-assessed Per irRECIST | 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 | To evaluate DCR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST. |
| Secondary | Investigator-assessed PFS Rate at 2 Years | 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 | To evaluate the PFS rate at 2 years in each treatment arm by investigator |
| Secondary | OS Rate at 2 Years | Up to approximately 2 years | To evaluate the OS rate at 2 years in each treatment arm |
| Secondary | PFS Investigator-assessed Per irRECIST | 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 | To evaluate PFS of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT03581786/registered