Trial · NCT07529613
Trastuzumab Deruxtecan Plus Nivolumab Plus Capecitabine Plus Oxaliplatin for HER2 Low Gastric and Gastroesophageal Junction Adenocarcinoma
NCT07529613, Phase 1, Phase 2, Completed, National Cancer Center Hospital East
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Trastuzumab Deruxtecan Plus Nivolumab Plus Capecitabine Plus Oxaliplatin for HER2 Low Gastric and Gastroesophageal Junction Adenocarcinoma. Trials, record NCT07529613. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07529613
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trastuzumab Deruxtecan Plus Nivolumab Plus Capecitabine Plus Oxaliplatin for HER2 Low Gastric and Gastroesophageal Junction Adenocarcinoma
- NCT number
- NCT07529613
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- National Cancer Center Hospital East
- Conditions
- Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- Interventions
- T-DXd, Nivolumab, Capecitabine, Oxaliplatin
- First posted
- 2026-04-14
- Last updated
- 2026-04-14
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of DLTs in Phase Ib part | 3 weeks | The incidence of DLTs in each cohort will be calculated for the DLT evaluable population. |
| Primary | ORR in Phase II part | 1 year | The ORR is defined as the proportion of participants whose best overall response, as assessed by the principal investigator or sub-investigator according to the RECIST guidelines version 1.1, is either CR or PR. |
| Secondary | Duration of Response (DoR) | 1 year | The duration is defined as the period from the date on which a complete response (CR) or partial response (PR) was first confirmed based on the overall response according to the RECIST Guidelines version 1.1, up to the earlier of the date on which disease progression (PD based on imaging) was determined or the date of death from any cause. |
| Secondary | Disease Control Rate (DCR) | 1 year | The DCR is defined as the proportion of participants whose best overall response according to the RECIST guidelines version 1.1 was CR or PR, or whose SD persisted for 6 weeks or longer. |
| Secondary | Progression-Free Survival (PFS) | 1 year | The period is calculated from the date of registration until the earlier of the date of confirmed progression or the date of death from any cause. |
| Secondary | Overall Survival (OS) | 1 year | The period is calculated from the date of registration until the date of death from any cause. |
| Secondary | Incidence of adverse events | 1 year | The treatment-emergent AEs will be summarized by CTCAE v5.0 |
| Other | HER2 expression at central review | 1 year | Analysis of efficacy in cases confirmed to have low HER2 expression at central review (ORR, PFS, DoR, DCR, OS) |
| Other | Evaluation of tumor tissue biomarkers by immunohistochemistry/in situ hybridization and RNA sequencing in the PhIb and PhII cohorts | 1 year | This outcome measure relates to an ancillary biomarker research study conducted as part of the main trial. Exploratory assessment of tumor tissue biomarkers will be performed using archived FFPE tumor specimens, including PD-L1, CD8, CD4, EBER-ISH, MMR protein expression, CLDN18.2, EGFR, FGFR, and MET expression by immunohistochemistry and/or in situ hybridization, and gene expression profiling by RNA sequencing. |
Source ClinicalTrials.gov
Outcomes0
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/NCT07529613
GET https://conductscience.org/api/trials/v1/NCT07529613/registered