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Trial · NCT07337447

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryOverall survival (%) between FOLFIRI and FOLFIRI+Zimberelimab+Domvanalimab6 months after the start of treatment 12 months after the start of treatmentLength of time from randomization that patients included in the study are still alive. Analyzed in modified intention to treat
SecondaryProgression free survival (PFS)From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 monthsTime from randomization to disease progression or death, whatever the cause. Alive and no progressive patients at last follow-up will be considered as censored
SecondaryOverall response rate (ORR)From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 monthslocal radiological evaluation using RECIST 1.1
SecondaryDuration of response (DoR)From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 monthsTime from response (complete or partial) to progression or death, estimated in patients who reached a response and are RECIST 1.1 evaluable
SecondaryDisease control rateFrom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 monthsDefined as the proportion of RECIST 1.1 evaluable patients in objective response or with stable disease.
SecondaryEvaluation of toxicityAt the Day 1 of each cycles (each cycle is 4 weeks)assessed by NCI CTCAsE v5.0
SecondaryEvaluation of toxicityat the Day 15 of each cycles (each cycle is 4 weeks)assessed by NCI CTCAsE v5.0
SecondaryQuestionnaire Quality of life QLQ-C30at the day 1 of Cycle 2 (1 cycle is 4 weeks)Questionnaire QLQ-C30
SecondaryQuestionnaire Quality of life EQ 5D-5Lat the day 1 of Cycle 2 (1 cycle is 4 weeks)Questionnaire EQ 5D-5L
SecondaryQuestionnaire Quality of lifeEvery 8 weeks through study completion, an average of 2 yearsQuestionnaire QLQ-C30
SecondaryQuestionnaire Quality of lifeEvery 8 weeks through study completion, an average of 2 yearsQuestionnaire EQ 5D-5L

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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