Trial · NCT07347314
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective response rate by central review | Overall response will be assessed every 8 weeks through 24 weeks, then every 12 weeks thereafter, from baseline up to 3 years or until disease progression or post-study treatment, whichever occurs first. | The objective response rate is defined as the proportion of patients in the full analysis set whose best overall response is a complete response (CR) or partial response (PR). Best overall response is defined as the best response recorded among CR, PR, stable disease (SD), progressive disease (PD), and not evaluable (NE) using RECIST version 1.1. |
| Secondary | Objective response rate by institutional review | Overall response will be assessed every 8 weeks through 24 weeks, then every 12 weeks thereafter, from baseline up to 3 years or until disease progression or post-study treatment, whichever occurs first. | Objective response rate is defined as the proportion of patients in the full analysis set whose best overall response is a complete response (CR) or partial response (PR). Best overall response is defined as the best response recorded among CR, PR, stable disease (SD), progressive disease (PD), and not evaluable (NE) using RECIST version 1.1. |
| Secondary | Progression-free survival | From baseline up to 3 years | Progression-free survival for each participant in the full analysis set is defined as the period from the date of enrollment to the date on which PD is confirmed by institutional review or the date of death from any cause, whichever comes first. |
| Secondary | Overall survival | From baseline up to 3 years | Overall survival for each participant in the full analysis set is defined as the period from the date of enrollment to the date of death from any cause. |
| Secondary | Disease control rate | From baseline up to 3 years | Disease control rate is defined as the percentage of participants in the full analysis set with the best overall response of CR, PR, and SD. The disease control rate is calculated based on both institutional review and central review. |
| Secondary | Incidence of adverse events | From baseline up to 3 years | Incidence of adverse events is defined as the percentage of participants in the safety analysis set who experienced each adverse event. In addition, the frequency of the worst grade by CTCAE v5.0-JCOG will be calculated for each adverse event. |
| Secondary | Dose Intensity | From baseline up to 3 years | Dose Intensity is calculated for each participant as the actual total dose of the study drug administered from the start of treatment to the last dose, normalized by the participant's body weight at enrollment, divided by the treatment duration in weeks. |
| Secondary | Relative dose intensity | From baseline up to 3 years | Dose Intensity is calculated for each participant as the actual total dose of the study drug administered from the start of treatment to the last dose, normalized by the participant's body weight at enrollment, divided by the treatment duration in weeks. |
| Secondary | Duration of response | From baseline up to 3 years | Duration of response for each participant in the full analysis set is defined as the period from the date on which CR or PR is first confirmed to the date on which PD is confirmed by institutional review or the date of death from any cause, whichever comes first. |
| Secondary | Time to response | From baseline up to 3 years | Time to response for each participant in the full analysis set is defined as the period from the date of enrollment to the date on which CR or PR is first confirmed based on both institutional review and central review. |
| Other | Objective response rate according to Nectin-4 expression status | Overall response will be assessed every 8 weeks through 24 weeks, then every 12 weeks thereafter, from baseline up to 3 years or until disease progression or post-study treatment, whichever occurs first. | A subgroup analysis of the objective response rate is conducted according to Nectin-4 expression status at baseline.Nectin-4 expression is assessed on a scale of 0 to 3. |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07347314/registered