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Trial · NCT06680921

Registered outcomes15

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

ListOutcomeTime frameDescription
PrimaryProgression free survival(PFS) , as assessed by blinded independent review committee(BIRC) according to RECIST1.12 yearPFS was defined as the time from the date of randomization to the first documented disease progression or death from any cause, whichever occurrs first.
SecondaryProgression free survival(PFS) , as assessed by investigator according to RECIST1.12 yearPFS was defined as the time from the date of randomization to the first documented disease progression or death from any cause, whichever occurrs first.
SecondaryOverall Survival (OS)3 yearOS is the time from the date of randomization to death from any cause.
SecondaryThe incidence and severity of adverse events (AEs) and serious adverse events (SAEs)3 yearFrequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0
SecondaryBlood concentrationsAt five specified time points of the first 6 cycles (each cycle is 28 days)Blood concentrations of SIM0270 and everolimus
SecondaryObjective Response Rate (ORR) by investigator2 yearThe objective response rate is defined as the percentage of subjects with a complete response or partial response.
SecondaryObjective Response Rate (DOR) by investigator2 yearThe DoR is defined as the time from the date of first complete or partial response until the date of documented progression or death from any cause.
SecondaryORR by BIRC2 yearThe objective response rate is defined as the percentage of subjects with a complete response or partial response.
SecondaryDOR by BIRC2 yearThe DoR is defined as the time from the date of first complete or partial response until the date of documented progression or death from any cause.
SecondaryClinical benefit rate(CBR) by investigator2 yearThe clinical benefit rate is defined as the percentage of subjects with a complete response or partial response or stable disease for ≥24 weeks.
SecondaryCBR by BIRC2 yearThe clinical benefit rate is defined as the percentage of subjects with a complete response or partial response or stable disease for ≥24 weeks.
SecondaryTime To Progression (TTP) by investigator2 yearTTP is defined as the time from randomization until the date of first documented progression.
SecondaryTime To Progression (TTP) by BIRC2 yearTTP is defined as the time from randomization until the date of first documented progression.
SecondaryChange from baseline in EQ-5D-5L scores2 yearChange from baseline in EQ-5D-5L scores
SecondaryChange from baseline in FACT-B scores2 yearChange from baseline in FACT-B scores

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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