NCT06253650 (TRINITY) is a Phase 2 clinical trial of Experimental in Gastric Cancer, sponsored by Gruppo Oncologico del Nord-Ovest.

Who is sponsoring NCT06253650?

NCT06253650 is sponsored by Gruppo Oncologico del Nord-Ovest.

What drugs are being tested in NCT06253650?

Interventions in NCT06253650: Experimental, Control.

What condition does NCT06253650 study?

NCT06253650 studies Gastric Cancer, HER2-positive Gastric Cancer.

Is NCT06253650 still recruiting?

NCT06253650 is currently recruiting now. Last updated 13 June 2024.

Last reviewed 2024-06-13 · How we verify

NCT06253650: TRINITY

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Adjuvant TRastuzumab Deruxtecan for HER2-positive Gastroesophageal Cancer With Persistence of miNImal Residual Disease

Recruiting now Phase 2 Last updated 13 June 2024

What this trial tests

Phase 2 trial testing Experimental in Gastric Cancer in 46 participants. Currently enrolling.

Timeline

1 March 2024

Primary endpoint
1 March 2027

1 March 2028

Quick facts

Lead sponsor	Gruppo Oncologico del Nord-Ovest
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	46
Start date	1 March 2024
Primary completion	1 March 2027
Estimated completion	1 March 2028
Sites	1 location across Italy

Drugs / interventions tested

Experimental — full drug profile →
Control

Conditions studied

Gastric Cancer — all drugs for Gastric Cancer →
HER2-positive Gastric Cancer — all drugs for HER2-positive Gastric Cancer →

Sponsor

Gruppo Oncologico del Nord-Ovest — full company profile →

Who can join

18 and older, any sex, with Gastric Cancer or HER2-positive Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

TRINITY is designed as a multicentre, randomized, open-label, interventional phase II study aimed at investigating the activity, efficacy and safety of trastuzumab-deruxtecan (T-DXd) plus capecitabine/5-fluorouracil as a post-operative treatment in localized/locally advanced gastric or gastroesophageal junction cancer (GC/GEJC)/esophageal adenocarcinoma patients with HER2 overexpression/amplification and positive post-operative ctDNA after pre-operative 5-fluorouracil plus leucovorin, oxaliplatin, and docetaxel (FLOT) regimen followed by radical surgery.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

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 multicentre, pha
Nasca V, Bergamo F, Foltran L, Antonuzzo L, et al · · 2025 · cited 7× · PMID 40200187 · DOI 10.1186/s12885-025-14063-6
Japan society of clinical oncology position paper on appropriate clinical use of molecular residual disease (MRD) testing.
Kobayashi S, Nakamura Y, Hashimoto T, Bando H, et al · · 2025 · cited 6× · PMID 39920551 · DOI 10.1007/s10147-024-02683-0
Perioperative Treatment in Gastric Cancer: A Fast-Changing Field.
Costa M, Lopes Fernandes C, Magalhães H. · · 2024 · cited 4× · PMID 39682222 · DOI 10.3390/cancers16234036
Blood-Based Surveillance Biomarkers for Gastroesophageal Cancers.
Dadgar N, Anees M, Sherry C, Park HY, et al · · 2025 · cited 2× · PMID 41228346 · DOI 10.3390/cancers17213552
Advancements in targeted therapy for gastric cancer.
Wang Y, Li J, Liu G, Zhang C, et al · · 2026 · PMID 42004816 · DOI 10.1177/17562848261439234
Evaluating trastuzumab deruxtecan in patients with gastrooesophageal adenocarcinoma who are ctDNA and HER2 positive: DECIPHER.
Smyth E, Griffiths D, Cozens K, Ewings S, et al · · 2024 · PMID 41646956 · DOI 10.1016/j.esmogo.2024.100114
Trastuzumab deruxtecan in the treatment of HER2-positive gastric cancer: a comprehensive review.
Jubashi A, Nakayama I, Shitara K. · · 2025 · PMID 41257369 · DOI 10.1080/14796694.2025.2589996

Verify or expand the search:

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Other recruiting trials for Gastric Cancer

Currently open trials in the same condition.

NCT07525765 — AI-assisted Decision-making of Reoperation for Postoperative Bleeding of Gastric Cancer · recruiting
NCT07464470 — Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Gastroesophageal Cancers · recruiting
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NCT07431281 — Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Meta · Phase 3 · recruiting
NCT07448493 — Local Treatment Strategies for Brain Metastases of Gastric and Esophageal Cancer · active not recruiting

Other Gruppo Oncologico del Nord-Ovest trials

Trials by the same sponsor.

NCT07407465 — Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal · Phase 2 · recruiting
NCT06897644 — Gemcitabine Plus Nab-paclitaxel as Switch Maintenance Versus Continuation of Modified FOLFIRINOX as 1st Line Chemotherap · Phase 3 · recruiting
NCT06869473 — Cetuximab Plus Platinum and Taxane-based Chemotherapy, Followed by Avelumab and Cetuximab, as First-line Treatment for R · Phase 2 · recruiting
NCT06733038 — FOLFOXIRI Plus Bevacizumab With or Without Atezolizumab as 1st Line Treatment of pMMR and IS IC-High Metastatic Colorect · Phase 3 · recruiting
NCT06578559 — Phase II Study of ctDNA-guided Encorafenib Plus Cetuximab Retreatment in Patients BRAF V600E Mutated mCRC · Phase 2 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06253650 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gruppo Oncologico del Nord-Ovest
Last refreshed: 13 June 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06253650.

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