Trial · NCT07069712
A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma
NCT07069712, Phase 2, Recruiting, AstraZeneca
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma. Trials, record NCT07069712. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07069712
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma
- NCT number
- NCT07069712
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 100 participants, estimated
- Lead sponsor
- AstraZeneca
- Conditions
- Gastroesophageal Adenocarcinoma
- Interventions
- Sonesitatug Vedotin, Rilvegostomig, Trastuzumab Deruxtecan (T-DXd), Capecitabine, 5-Fluorouracil (5-FU), FLOT Chemotherapy, Calcium folinate
- First posted
- 2025-07-17
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07069712
GET https://conductscience.org/api/trials/v1/NCT07069712/registered