Trial · NCT07407465
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate | 24 months | Overall response rate will be defined as the proportion of patients who achieve either a partial or complete response as best responses to study treatment according to RECIST v1.1 criteria. Response will be assessed as per blinded independent central review |
| Secondary | Progression-free survival | 24 months | Progression-free survival is defined as the time from treatment start to radiological evidence of disease progression (as per RECIST v1.1 criteria) or death, whichever occurs first. PFS will be assessed by BICR and Investigator-assessed. |
| Secondary | Overall survival | 48 months | Overall survival is defined as the time from treatment start to death. |
| Secondary | Treatment safety | 24 months | Treatment safety is defined as the incidence of adverse events during treatment and follow-up, assessed according to CTCAE v5.0. |
| Secondary | Disease control rate | 24 months | Disease control rate (DCR) by BICR and Investigator assessment, defined as the proportion of subjects achieving a complete response (CR), partial response (PR) or stable disease (SD) as best response during study treatment, as per RECIST v1.1. |
| Secondary | Early tumor shrinkage | 24 months | Early tumor shrinkage (ETS), defined as the proportion of patients achieving a reduction in tumor size of at least 20% at first radiological reassessment. |
| Secondary | Duration of response | 24 months | Duration of response (DOR), defined as the time from first radiological evidence of complete or partial response to disease progression or death whichever occurs first. |
| Secondary | Depth of response | 24 months | Depth of response (DoR) defined as the maximum percentage of tumor shrinkage at best response relative to baseline. |
| Secondary | CEA dynamics | 24 months | Serum carcinoembryonic antigen (CEA) concentration will be measured in peripheral blood using standard-of-care clinical laboratory immunoassays performed at participating sites. The unit of measure will be ng/mL. CEA kinetics will be summarized as: (i) absolute CEA values (ng/mL) over time; (ii) change from baseline (absolute and percent change); and (iii) CEA normalization (conversion to within institutional normal range) when applicable. CEA dynamics will be assessed at baseline, every 9 (+/-1) weeks during treatment, at EOT and during follow-up visits through 24 months. Associations will be explored between CEA kinetics and efficacy/activity outcomes including objective response (per RECIST v1.1), duration of response, progression-free survival and overall survival, using correlation/association analyses |
| Secondary | Central review of HER-2 status | 24 month | Tumor HER2 status will be centrally assessed on archival tumor tissue on which local HER-2 positivity was assessed. HER-2 testing will be performed by means of immunohistochemistry (IHC) assay with in situ hybridization (ISH) in case of IHC 2+ scores. HER2 status will be evaluated according to the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines for gastric/gastroesophageal cancer. The measure will be reported as HER2 IHC score category, ISH result (where applicable), and overall central HER2 status (positive vs negative). Concordance between central and local HER2 results will be evaluated using percent agreement (overall/positive/negative agreement as applicable) and Cohen's kappa statistic. Exploratory associations between centrally confirmed HER2 status (and/or HER2 categories) and efficacy/activity outcomes (objective response per RECIST v1.1, progression-free survival, overall survival) will be assessed. |
| Secondary | Quality of life as assessed by the European Organization for Research and Treattment of Cancer (EORTC) QLQ-C30 | 24 months | Quality of life will be assessed through Patients reported outcomes (completion of quality-of-life questionnaires, European Organization for Research and Treattment of Cancer (EORTC) QLQ-C30 during treatment). Questionnaires will be administered at baseline, every 9 weeks +/- 7 days during treatment and at the end of treatment. |
| Secondary | CA19.9 dynamics | 24 months | Serum carbohydrate antigen 19-9 (CA19-9) concentration will be measured in peripheral blood using standard-of-care clinical laboratory immunoassays performed at participating sites. The unit of measure will be U/mL. CA19-9 kinetics will be summarized as: (i) absolute CA19-9 values (U/mL) over time; (ii) change from baseline (absolute and percent change); and (iii) CA19-9 normalization (conversion to within institutional normal range) when applicable. CA19-9 dynamics will be assessed at baseline, every 9 (+/- 1) weeks during treatment, at EOT and during follow-up visits through 24 months. Associations will be explored between CA19-9 kinetics and efficacy/activity outcomes including objective response (per RECIST v1.1), duration of response, progression-free survival and overall survival, using correlation/association analyses. |
| Secondary | Quality of life as assessed by the European Organization for Research and Treattment of Cancer (EORTC) QLQ-CR-29 | 24 months | Quality of life will be assessed through Patients reported outcomes (completion of quality-of-life questionnaires, European Organization for Research and Treattment of Cancer (EORTC) QLQ-CR-29 during treatment). Questionnaires will be administered at baseline, every 9 weeks +/- 7 days during treatment and at the end of treatment. |
| Secondary | Quality of life as assessed by the European Organization for Research and Treattment of Cancer (EORTC) EuroQol EQ-5D | 24 months | Quality of life will be assessed through Patients reported outcomes (completion of quality-of-life questionnaires, European Organization for Research and Treattment of Cancer (EORTC) EuroQol EQ-5D during treatment). Questionnaires will be administered at baseline, every 9 weeks +/- 7 days during treatment and at the end of treatment. |
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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