Trial · NCT07407465
Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer.
NCT07407465, Phase 2, Recruiting, Gruppo Oncologico del Nord-Ovest
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer. Trials, record NCT07407465. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07407465
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer.
- NCT number
- NCT07407465
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 42 participants, estimated
- Lead sponsor
- Gruppo Oncologico del Nord-Ovest
- Conditions
- Colorectal Cancer, Colorectal Adenocarcinoma, Rectal Adenocarcinoma, Rectal Cancer, Adenocarcinoma, Rectal Cancer, Metastatic, Colon Cancer Metastatic, Colon Cancer Adenocarcinoma
- Interventions
- Trastuzumab-Deruxtecan (T-DXd), Capecitabine, Bevacizumab
- First posted
- 2026-02-12
- Last updated
- 2026-02-17
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 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/NCT07407465
GET https://conductscience.org/api/trials/v1/NCT07407465/registered