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Trial · NCT06055465

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryPathological complete response (pCR) rate in the intention-to-treat population2 years
SecondaryResection rate after neoadjuvant SG and pembrolizumab combination: proportion of patients who undergo surgery with curative intent2 years
SecondarypCR rates in patients who undergo surgery2 years
SecondaryMajor pathological response (MPR) rate in the ITT population and in patients who undergo surgery: MPR is defined as less than 10% viable tumor cells in resected primary tumour specimen2 years
SecondaryNumber of participants with treatment-related adverse events as assessed by CTCAE v5.0 while on neoadjuvant SG and pembrolizumab combination2 years
SecondaryNumber of participants with treatment-related adverse events as assessed by CTCAE v5.0 while on adjuvant pembrolizumab2 years
SecondaryNumber of participants with treatment-related adverse events as assessed by CTCAE v5.0 first 30 days after surgery2 years
SecondaryObjective response rate (ORR): rate of partial and complete response on CT scans according to RECIST criteria ver 1.12 years
SecondaryOverall Survival2 years
Secondary12 month and 24 month event-free survival (EFS) rate2 years
SecondaryPatient reported quality of life (QOL), as measured by EQ-5D-3L during study treatment.2 years
For the descriptive system of EQ-5D-3L, three levels of problems are described in each dimension. For the Visual Analogue Scale (VAS), the overall health assessment of the respondent is captured, ranging from 0 (worst health imaginable) to 100 (best health imaginable)

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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