Trial · NCT05546853
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Proportion of patients experiencing adverse events | At 6 months | Percentage Proportion of patients experiencing adverse events (AEs) of any grade and grade 3/4 AEs as defined by the National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE v 5.0) at 6 months. |
| Secondary | Best overall objective response rate (ORR) | At 3,6,9 and 12 months | Best overall objective response rate (ORR) and ORR at 3 months, 6, 9, 12 months according to RECIST 1.1 |
| Secondary | Overall survival (OS) | at 6, 12 and 36 months | Median Overall survival (OS), 6 months and 12 months-OS rates. OS is defined as the time between inclusion and death (all causes). Patients alive will be censored at the date of last news. |
| Secondary | Progression-Free Survival (PFS) | at 6, 12 and 36 months | Median Progression-Free Survival (PFS), 6 months and 12 months-PFS rates. PFS is defined as the time between inclusion and progression according to RECIST 1.1 or death (all causes). Patients alive without progression will be censored at the date of last news. |
| Secondary | Median Duration of response | at 6 and 36 months | Median Duration of response is defined as the time between first dose of treatment and progression according to RECIST 1.1. Patients alive without progression will be censored at 6 months and at the date of last news. |
| Secondary | Quality of life (QoL) | at 6 and 36 months | Quality of life will be studied by using the EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire for Cancer) at 6 months and at the end of study. A 5-point decrease of QLQ-C30 score will be considered as the minimal clinically significant deterioration of QoL. |
| Secondary | time to deterioration | at 6 and 36 months | TTD will be defined as the time from inclusion in the study to deterioration of EORTC QLQ-C30 score with a decrease ≥5 points at any time point after the baseline score, at 6 months and at the end of study |
| Secondary | PK-PD evaluation | at 36 months | PK-PD evaluation: based on available PopPK modelisation and PK samples collected at the time of the response evaluation in this study |
| Secondary | CA19.9 response | at 6 and 12 months | CA19.9 response will be defined as a percentage of patients with a ≥ 50% reduction from baseline CA19.9 level, at 6 and 12 months. |
| Secondary | proportion of patients reaching surgery | at 6 and 36 months | Percentage surgical resection with R0/R1 margins at 6 months and at the end of study. |
| Secondary | Mechanisms of EMT | At month 0 | To assess the mechanisms of EMT reversal by comparing different histological markers on pre-therapeutic biopsies with tumor samples obtained during surgical tumor resection. Descriptive study in spatial transcriptomics and immunohistochemistry of the evolution of EMT markers, Netrin-1 expression, and tumor microenvironment by comparing pre-therapeutic biopsies to tumor samples obtained during surgical tumor resection |
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
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GET https://conductscience.org/api/trials/v1/NCT05546853/registered