Trial · NCT05394740
Clinical Study of Regorafenib and Nivolumab Plus Chemotherapy
NCT05394740, Phase 1, Phase 2, Completed, National Cancer Center Hospital East
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Study of Regorafenib and Nivolumab Plus Chemotherapy. Trials, record NCT05394740. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05394740
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study of Regorafenib and Nivolumab Plus Chemotherapy
- NCT number
- NCT05394740
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- National Cancer Center Hospital East
- Conditions
- Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma
- Interventions
- Regorafenib, Nivolumab, CapeOX, FOLFOX regimen
- First posted
- 2022-05-27
- Last updated
- 2026-04-09
Source ClinicalTrials.gov
Registered outcomes8
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 | 4weeks | The incidence of DLTs in each cohort will be calculated for the DLT evaluable population. |
| Primary | ORR in Phase II part | 1 year | ORR is defined as the proportion of subjects whose best overall response based on the RECIST guideline version 1.1 is either CR or PR. |
| Secondary | PFS | 1 year | Progression-free survival is defined as the time from the enrollment date until the date when disease progression is determined or until the date of death from any cause, whichever comes earlier. |
| Secondary | DoR | 1 year | DoR is defined in responders as the period from the date of the first determination of overall response as CR or PR according to the RECIST guideline version 1.1 to the date of determination of progression (PD based on diagnostic imaging) or the date of death from any cause, whichever comes first. |
| Secondary | DCR | 1 year | DCR is defined as the proportion of patients in whom the best overall response was determined as CR or PR, or patients who maintained SD for 6 weeks or more according to the RECIST guideline version 1.1. |
| Secondary | OS | 2 years | The period will be from the day of enrollment, as the starting date of the computation, to the day of death of any cause. |
| Secondary | Incidence of adverse events | up to 30 days after the last dose | The treatment-emergent AEs will be summarized by CTCAE v5.0 |
| Other | Biomarkers in the PhIb and PhII cohort | 1 year | Change of ctDNA and examination of various biomarkers |
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/NCT05394740
GET https://conductscience.org/api/trials/v1/NCT05394740/registered