Trial · NCT07347314
Enfortumab Vedotin in Patients With Advanced Small Bowel Adenocarcinoma Refractory or Intolerant to Platinum-based Combination Therapy
NCT07347314, Phase 2, Recruiting, National Cancer Center, Japan
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Enfortumab Vedotin in Patients With Advanced Small Bowel Adenocarcinoma Refractory or Intolerant to Platinum-based Combination Therapy. Trials, record NCT07347314. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07347314
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Enfortumab Vedotin in Patients With Advanced Small Bowel Adenocarcinoma Refractory or Intolerant to Platinum-based Combination Therapy
- NCT number
- NCT07347314
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 27 participants, estimated
- Lead sponsor
- National Cancer Center, Japan
- Conditions
- Advanced Small Bowel Adenocarcinoma
- Interventions
- Enfortumab vedotin
- First posted
- 2026-01-16
- Last updated
- 2026-03-11
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective response rate by central review | Overall response will be assessed every 8 weeks through 24 weeks, then every 12 weeks thereafter, from baseline up to 3 years or until disease progression or post-study treatment, whichever occurs first. | The objective response rate is defined as the proportion of patients in the full analysis set whose best overall response is a complete response (CR) or partial response (PR). Best overall response is defined as the best response recorded among CR, PR, stable disease (SD), progressive disease (PD), and not evaluable (NE) using RECIST version 1.1. |
| Secondary | Objective response rate by institutional review | Overall response will be assessed every 8 weeks through 24 weeks, then every 12 weeks thereafter, from baseline up to 3 years or until disease progression or post-study treatment, whichever occurs first. | Objective response rate is defined as the proportion of patients in the full analysis set whose best overall response is a complete response (CR) or partial response (PR). Best overall response is defined as the best response recorded among CR, PR, stable disease (SD), progressive disease (PD), and not evaluable (NE) using RECIST version 1.1. |
| Secondary | Progression-free survival | From baseline up to 3 years | Progression-free survival for each participant in the full analysis set is defined as the period from the date of enrollment to the date on which PD is confirmed by institutional review or the date of death from any cause, whichever comes first. |
| Secondary | Overall survival | From baseline up to 3 years | Overall survival for each participant in the full analysis set is defined as the period from the date of enrollment to the date of death from any cause. |
| Secondary | Disease control rate | From baseline up to 3 years | Disease control rate is defined as the percentage of participants in the full analysis set with the best overall response of CR, PR, and SD. The disease control rate is calculated based on both institutional review and central review. |
| Secondary | Incidence of adverse events | From baseline up to 3 years | Incidence of adverse events is defined as the percentage of participants in the safety analysis set who experienced each adverse event. In addition, the frequency of the worst grade by CTCAE v5.0-JCOG will be calculated for each adverse event. |
| Secondary | Dose Intensity | From baseline up to 3 years | Dose Intensity is calculated for each participant as the actual total dose of the study drug administered from the start of treatment to the last dose, normalized by the participant's body weight at enrollment, divided by the treatment duration in weeks. |
| Secondary | Relative dose intensity | From baseline up to 3 years | Dose Intensity is calculated for each participant as the actual total dose of the study drug administered from the start of treatment to the last dose, normalized by the participant's body weight at enrollment, divided by the treatment duration in weeks. |
| Secondary | Duration of response | From baseline up to 3 years | Duration of response for each participant in the full analysis set is defined as the period from the date on which CR or PR is first confirmed to the date on which PD is confirmed by institutional review or the date of death from any cause, whichever comes first. |
| Secondary | Time to response | From baseline up to 3 years | Time to response for each participant in the full analysis set is defined as the period from the date of enrollment to the date on which CR or PR is first confirmed based on both institutional review and central review. |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39754977 | RESULT |
Source PubMed
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/NCT07347314
GET https://conductscience.org/api/trials/v1/NCT07347314/registered