Trial · NCT04879368
RegoNivo vs Standard of Care Chemotherapy in AGOC
NCT04879368, Phase 3, Completed, Australasian Gastro-Intestinal Trials Group
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. RegoNivo vs Standard of Care Chemotherapy in AGOC. Trials, record NCT04879368. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04879368
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RegoNivo vs Standard of Care Chemotherapy in AGOC
- NCT number
- NCT04879368
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 462 participants, actual
- Lead sponsor
- Australasian Gastro-Intestinal Trials Group
- Conditions
- Gastro-Oesophageal Cancer
- Interventions
- Regorafenib, Nivolumab, Docetaxel, Paclitaxel, Irinotecan, Trifluridine/Tipracil
- First posted
- 2021-05-10
- Last updated
- 2026-06-10
- Other registries' IDs
- eudract:2020-004617-12
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | O/S | From the date of randomisation to date of death from any cause or the date last known alive, assessed up to approximately 44 months. | To determine the effect of RegoNivo on overall survival (OS) (death from any cause) in the overall study population and in the Asian sub-population. Overall survival is defined as the interval from the date of randomisation to date of death from any cause, or the date last known alive. |
| Secondary | Determine the Effect of RegoNivo on; PFS | From the date of randomisation to the date of first evidence of disease progression or death, whichever occurs first, assessed up to approximately 44 months. | A PFS (Progressive free survival) event is defined as the first occasion that either RECIST criteria and iRECIST for disease progression are met, a patient is judged to have progressed by the responsible investigator (in the event that no RECIST assessment is available) or death occurs. Progression is defined using RECIST v1.1 and iRECIST, as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum of diameters recorded in the study (including baseline) and an absolute increase of at least 5mm. The appearance of one or more new lesions is also considered progression. In exceptional circumstances, unequivocal progression of non-target disease was accepted as evidence of disease progression, where the overall tumour burden has increased sufficiently to merit discontinuation of treatment or where the tumour burden appears to have increased by at least 73% in volume. |
| Secondary | Determine the Effect of RegoNivo on; OTRR | From randomisation until disease progression, with tumour assessments performed every 8 weeks (±7 days), assessed up to approximately 44 months. | Number of participants achieving a Partial Response (PR) or Complete Response (CR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 and iRECIST. Complete Response (CR): Disappearance of all target and non-target lesions and normalisation of any specified tumour markers Partial Response (PR): \>=30% decrease in the sum of diameters of target lesions (longest diameter for tumour lesions and short axis measure for target lymph nodes), taking as reference the baseline sum of diameters. |
| Secondary | Deterioration-Free Survival (DFS) Based on Physical Function (EORTC QLQ-C30) | 6 months and 12 months after randomisation. | Quality of life (scores from participant-completed questionnaires) of participants on study EORTC QoL Questionnaire: QLQ-C30: Q1 - Q28, Min 1 Max 4, Higher Score = Worse QLQ-C30: Q29 \& Q30 Min 1 Max 7, Higher = Better Deterioration-Free Survival (DFS) rate based on Physical Function is defined as the percentage of participants who have not experienced deterioration, disease progression, death, or treatment discontinuation at the specified time point. Deterioration is defined as a ≥10-point decrease from baseline in the Physical Function scale of the EORTC QLQ-C30, without a subsequent ≥10-point improvement compared with baseline. Physical function is assessed using the EORTC QLQ-C30 Physical Function Scale to identify the percentage of participants who were deterioration-free at 6 months and 12 months. |
| Secondary | Deterioration-Free Survival Rate Based on Global Health Status (EORTC QLQ-C30) | 6 months and 12 months after randomisation | Quality of life (QoL)(scores from participant-completed questionnaires) of participants on study EORTC Quality of Life Questionnaire: EORTC QLQ-C30: Q1 - Q28, Min 1 Max 4, Higher Score = Worse EORTC QLQ-C30: Q29 \& Q30 Min 1 Max 7, Higher = Better Deterioration-Free Survival (DFS) rate based on Global Health Status is defined as the percentage of participants who have not experienced any of the following events by the specified time point; A ≥10-point deterioration from baseline in the Global Health Status/QoL scale of the EORTC QLQ-C30, without a subsequent ≥10-point improvement, disease progression, death from any cause or treatment discontinuation. Global Health Status is assessed using the EORTC QLQ-C30 Global Health Status to identify the percentage of participants who were deterioration free at 6 months and 12 months. |
| Secondary | Determine the Effect of RegoNivo on; Safety | From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months. | Safety (rates of adverse events) of participants on study |
| Other | Prognostic Biomarker Identification for AGOC | Up to 24 months following close of study. | To identify prognostic and predictive biomarkers (tissue and circulating) for study endpoints (relating to survival, response and safety). |
| Other | Regorafenib Max Plasma Concentration Level Assessment (Cmax) Across Geographical Regions | Up to 24 months following close of study. | To evaluate regorafenib Cmax in patient populations from different geographical regions (regorafenib levels). |
| Other | Regorafenib Levels and Correlation to Treatment | Up to 24 months following close of study. | To evaluate regorafenib levels and their correlation to outcomes in treatment |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36814222 | DERIVED |
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/NCT04879368
GET https://conductscience.org/api/trials/v1/NCT04879368/registered