Trial · NCT06023862
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival | Up to approximately 48 months | The time from the date of randomization until first documentation of disease progression, as determined by investigator assessment based on RECIST 1.1, or death due to any cause, whichever occurs first. |
| Secondary | Objective Response Rate | Up to approximately 48 months | the proportion of patients who have best overall response of either complete response (CR) or partial response (PR), as investigator assessment based on RECIST 1.1 |
| Secondary | Disease control rate | Up to approximately 48 months | the proportion of patients who have best overall response of CR, PR, or stable disease (SD) by investigator assessment per RECIST 1.1 . SD must be achieved at ≥ 7 weeks after randomization to be considered best overall response. |
| Secondary | Clinical benefit rate | Up to approximately 48 months | the proportion of patients who have best overall response of CR, PR, or stable disease (SD) by investigator assessment per RECIST 1.1 . (duration of SD ≥ 23 weeks after randomization) |
| Secondary | Progression Free Survival 2 | Up to approximately 72 months | the time from initial randomization to the second objective disease progression (ie, after the first subsequent therapy) or death. |
| Secondary | Overall survival | Up to approximately 72 months | the time from the date of randomization until death due to any cause |
| Secondary | Duration of Response Rate | Up to approximately 48 months | Measured from the time of initial response until documented tumor progression. |
| Secondary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Up to approximately 72 months | Assessed by CTCAE v5.0 (by investigators). |
| Secondary | Time to first and second Subsequent Treatment | Up to approximately 72 months | the time from the date of randomization to date of the first and second subsequent anticancer therapy or death. |
| Secondary | Response rate of subsequent therapies | Up to approximately 72 months | the proportion of patients who have best overall response of either complete response (CR) or partial response (PR), as investigator assessment based on RECIST 1.1 |
| Other | Disease-related or Treatment-related Biomarkers | At the end of study, Up to approximately 72 months | Translational research including NGS as well as MMRd, MSI-H, PD1/L1, TMB, Immune signature, and Tie-2. |
| Other | Comparison of RECIST1.1 and i-RECIST assessment | Throughout duration of study, Up to 48 months | By comparing RECIST 1.1 and iRECIST, evaluate the accuracy of iRECIST for assessing the therapeutic efficacy of ICIs. |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT06023862/registered