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Trial · NCT06698965

Registered outcomes18

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

ListOutcomeTime frameDescription
PrimaryThe incidence of grade ≥ 3 neutropenia during chemotherapy treatmentFrom enrollment to the end of Cycle 6 (each cycle is 21 days)According to CTCAE5.0
SecondaryThe incidence of ≥ grade 3 thrombocytopenia or anemia during chemotherapyFrom enrollment to the end of Cycle 6 (each cycle is 21 days)
SecondaryThe duration of severe neutropenia in the first treatment cycleFrom enrollment to the end of Cycle 1 (each cycle is 21 days)
SecondaryThe incidence of febrile neutropenia during chemotherapyFrom enrollment to the end of Cycle 6 (each cycle is 21 days)
SecondaryThe usage rate of granulocyte colony-stimulating factor (PEG-G-CSF/G-CSF) during chemotherapyFrom enrollment to the end of Cycle 6 (each cycle is 21 days)
SecondaryDisease burden of patients during chemotherapyFrom enrollment to the end of Cycle 6 (each cycle is 21 days)Based on EQ-5D-5L scales scores(The score range is from 5 to 25 points, with higher scores indicating better outcomes)
SecondaryThe usage rate of erythropoietin (ESA) during chemotherapyFrom enrollment to the end of Cycle 6 (each cycle is 21 days)
SecondaryThe usage rate of recombinant human interleukin-11 during chemotherapyFrom enrollment to the end of Cycle 6 (each cycle is 21 days)
SecondaryThe usage rate of thrombopoietin (TPO) during chemotherapyFrom enrollment to the end of Cycle 6 (each cycle is 21 days)
SecondaryThe usage rate of iron supplement during chemotherapyFrom enrollment to the end of Cycle 6 (each cycle is 21 days)
SecondaryThe incidence of platelet transfusion during chemotherapyFrom enrollment to the end of Cycle 6 (each cycle is 21 days)
SecondaryThe incidence of red blood cell transfusion during chemotherapyFrom enrollment to the end of Cycle 6 (each cycle is 21 days)
SecondaryORRFrom enrollment to the end of Cycle 6 (each cycle is 21 days)Objective response rate
SecondaryDCRFrom enrollment to the end of Cycle 6 (each cycle is 21 days)disease control rate
SecondaryDORFrom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 monthsDuration of response
SecondaryPFSFrom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 monthsProgression-Free-Survival
SecondaryOSFrom date of randomization until the date of death from any cause, assessed up to 60 monthsOverall survival
OtherDynamic changes of immune cell subsets and cytokines in peripheral blood before and after treatmentFrom enrollment to the end of Cycle 6 (each cycle is 21 days)Including but not limited to the ratio of CD8+T/Treg and the number of T cell clones

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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