Trial · NCT07069712
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 | Number of participants with adverse events (AEs) and serious adverse events (SAEs) | Until sub-study completion, up to 38 months | To assess the safety and tolerability of perioperative treatment. |
| Primary | Percentage of participants with pathological complete response (pCR) | Until sub-study completion, up to 38 months | pCR is defined as no viable cancer cells, including lymph nodes after complete evaluation in the resected gastric, GEJ, or esophageal cancer specimen and all sampled regional lymph nodes following neoadjuvant treatment. |
| Secondary | Surgery completion rate | Until sub-study completion, up to 38 months | Surgery completion rate is defined as the percentage of participants who received gastrectomy or gastroesophagectomy or esophagectomy. |
| Secondary | R0 resection (complete resection) rate | Until sub-study completion, up to 38 months | R0 resection (complete resection) rate is the percentage of participants who received gastrectomy or gastroesophagectomy or esophagectomy and had a confirmed margin-negative resection. |
| Secondary | Percentage of participants with tumor downstaging | Until sub-study completion, up to 38 months | Tumor downstaging is defined as the lowering of the primary tumor (T) and/or regional lymph nodes (N) from pre-neoadjuvant clinical staging (pre-cTN) to post-neoadjuvant clinical staging (post-cTN) and to postoperative pathological staging (ypTN). |
| Secondary | Event-free survival (EFS) | Until sub-study completion, up to 38 months | EFS is defined as the time from the first dose of study intervention to documented Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or non-RECIST 1.1 disease progression that precludes radical surgery or requires non-protocol therapy during the neoadjuvant through surgery period, or to documented RECIST 1.1 or biopsy-confirmed non-RECIST 1.1 recurrence or progression of disease during the adjuvant period, or death due to any cause at any time. |
| Secondary | Disease-free survival (DFS) | Until sub-study completion, up to 38 months | DFS is defined as the time elapsed from the date of the first post-surgery scan (ie, Adjuvant Baseline scan) until the date of first evidence of disease recurrence as determined by Investigator using RECIST 1.1 assessment (local or distant), or death due to any cause, whichever occurs first. |
| Secondary | Objective response rate (ORR) | Until sub-study completion, up to 38 months | ORR is defined as the percentage of participants who have a CR or PR as determined by Investigator using RECIST 1.1 at their latest assessment prior to surgery. |
| Secondary | Overall survival (OS) | Until sub-study completion, up to 38 months | OS is defined as the time from the first dose of the study intervention until the date of death due to any cause regardless of whether participant withdraws from treatment or receives another anti-cancer therapy. |
| Secondary | Serum concentrations of study interventions | Until sub-study completion, up to 38 months | To assess the serum concentrations of study interventions in participants receiving perioperative treatment. |
| Secondary | Number of participants with positive anti-drug antibodies (ADA) | Until sub-study completion, up to 38 months | To assess the immunogenicity of study interventions in participants receiving perioperative 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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07069712/registered