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Adjuvant TRastuzumab deruxtecan plus fluoropyrimidine versus standard chemotherapy In HER2-positive gastric or gastroesophageal cancer patients with persistence of miNImal residual disease in liquid biopsy after pre-operative chemoTherapy and radical surgerY: the TRINITY study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506662-31-00
Enrollment
46
Registered
2024-01-18
Start date
2024-02-28
Completion date
Unknown
Last updated
2024-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric or gastroesophageal cancer

Brief summary

The rate of patients with ctDNA clearance after adjuvant T-DXd plus capecitabine/5-fluorouracil versus post-operative FLOT continuation treatment at 1 year from randomization in the intention-to-treat population. Patients with disease relapse or death before the 12-month post-randomization timepoint will be considered in the intention-to-treat population as not having achieved ctDNA clearance.

Detailed description

Disease-free survival, defined as time from the randomization in the study to the occurrence of disease relapse (local and/or distant), second GC/GEJC primary, or death from any cause, Overall survival, defined as time from the randomization in the study to the occurrence of death, Metastases-free survival, defined as time from the randomization in the study to the first evidence of metastases according to the radiological and clinical assessments detailed in the procedures or death from any cause

Interventions

DRUGDS-8201a
DRUGFLUOROURACIL
DRUGDOCETAXEL
DRUGCALCIUM LEVOFOLINATE
DRUGOXALIPLATIN
DRUGCAPECITABINE

Sponsors

Gruppo Oncologico Del Nord Ovest
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The rate of patients with ctDNA clearance after adjuvant T-DXd plus capecitabine/5-fluorouracil versus post-operative FLOT continuation treatment at 1 year from randomization in the intention-to-treat population. Patients with disease relapse or death before the 12-month post-randomization timepoint will be considered in the intention-to-treat population as not having achieved ctDNA clearance.

Secondary

MeasureTime frame
Disease-free survival, defined as time from the randomization in the study to the occurrence of disease relapse (local and/or distant), second GC/GEJC primary, or death from any cause, Overall survival, defined as time from the randomization in the study to the occurrence of death, Metastases-free survival, defined as time from the randomization in the study to the first evidence of metastases according to the radiological and clinical assessments detailed in the procedures or death from any cause

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026