Trial · NCT05927857
Ramucirumab (Cyramza), Nal-IRI (ONIVYDE) and Trifluridine/Tipiracil (Lonsurf) in Second Line Metastatic Gastric Cancer .
NCT05927857, Phase 1, Phase 2, Recruiting, National Health Research Institutes, Taiwan
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Ramucirumab (Cyramza), Nal-IRI (ONIVYDE) and Trifluridine/Tipiracil (Lonsurf) in Second Line Metastatic Gastric Cancer . Trials, record NCT05927857. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05927857
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ramucirumab (Cyramza), Nal-IRI (ONIVYDE) and Trifluridine/Tipiracil (Lonsurf) in Second Line Metastatic Gastric Cancer .
- NCT number
- NCT05927857
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 45 participants, estimated
- Lead sponsor
- National Health Research Institutes, Taiwan
- Conditions
- Metastatic Gastric Adenocarcinoma, Second Line, Chemotherapy
- Interventions
- nal-IRI /Experimental, Ramucirumab /Experimental, Trifluridine/Tipiracil /Experimental
- First posted
- 2023-07-03
- Last updated
- 2026-04-09
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To determine MTD (maximum tolerated dose) of nal-IRI (ONIVYDE) | Phase I last patient in has been treated for 28 days. | All treated patients of MTD dose level in phase 1b cohort will be incorporated into phase II cohort for final analysis. |
| Primary | To evaluate disease objective response rate (ORR) | Whichever occurs first assessed up to 24 months. | Based on results from phase Ib cohort, MTD will be determined. All treated population in MTD cohort will be incorporated into phase II cohort for final analysis. |
| Secondary | •To evaluate disease control rate (DCR) | The time from registration to death from any cause assessed up to 24 months. | •Patients will be treated until disease progression, unacceptable toxicity or other condition meeting the off-study criteria. |
| Secondary | •To evaluate progression-free survival (PFS) | The time from registration to occurrence of progression based on the tumor response assessment by scheduled or un- scheduled CT scan or MRI. (whichever occurs first assessed up to 24 months) | • objective tumor response according to RECIST v1.1 guidelines. |
| Secondary | •To evaluate overall survival (OS) | The time from registration to death from any cause assessed up to 24 months. | the time from the date of first study treatment to the date of patient death, due to any cause, or to the last date the patient was known to be alive. |
| Secondary | •To assess the safety profile | The time from registration to death from every 14 days assessed up to 24 months. | •Safety evaluations: physical examination, vital signs, body weight, ECOG performance status, clinical laboratory values (biochemistry, hematology, and urinalysis), and any adverse event (AE) graded by using CTCAE v5.0 if applicable. |
| Secondary | •To study the blood biomarkers | The time from baseline on day 1. | * To evaluate the drug sensitivity of circulating tumor cells to, including but not limited to irinotecan, fluorouracil and ramucirumab. * Patients enrolled in both phase Ib and phase II parts will participate in biomarker study |
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.
Papers15
The papers the trial lists on ClinicalTrials.gov.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT05927857
GET https://conductscience.org/api/trials/v1/NCT05927857/registered