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Trial · NCT06632405

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryOverall response rate (ORR)from the first drug administration up to the first occurrence of progression or death (up to 36 weeks)The propotion of subjects with CR or PR.
SecondaryAdverse events/Serious adverse eventsfrom the first drug administration to within 90 days for the last doseAdverse events/Serious adverse events
SecondaryDisease Control Rate (DCR)from the first drug administration up to the first occurrence of progression or death (up to 36 weeks)The propotion of subjects with CR, PR, or SD.
SecondaryClinical benefit rate (CBR)propotion of subjects with CR, PR, or SD for >=6 months (up to 36 weeks)The propotion of subjects with CR, PR, or SD for \>=6 months during the study
SecondaryDuration of response (DoR)from the first drug administration up to the first occurrence of progression or death (up to 36 weeks)The time from randomization to disease progression or death for patients who achieve complete or partial alleviation
SecondaryTime to response (TTR)from the first drug administration up to the first occurrence of progression (up to 36 weeks)Time from date of first dose to date of first occurrence of response
SecondaryProgression-Free-Survival (PFS)from the first drug administration up to the first occurrence of progression or death (up to 36 weeks)from the first drug administration up to the first occurrence of progression or death (up to 24 months)
SecondaryOverall survival (OS)12 months after the first drug administration12 months after the first drug administration
SecondaryBiomarkerspre-treatment, up to 24 monthsCompare the change of biomarkers from urine, blood or tissues, such as the carcinoembryonic antigen (ug/L), before or after the treatments.
SecondaryBiomarkerspre-treatment, up to 24 monthsCompare the change of biomarkers from urine, blood or tissues, such as the CA125/199/153(u/ml), before or after the treatments.
Secondarypatient reported outcomes (PRO)during the study and up to 36 weeks after the enddirect reports from patients about their health, the scale Quality of Life questionnaire (QLQ)-BR23/C30 will be used for assecessment. Higher score indicate better life quality

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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