Perioperative Therapies in Locally Advanced Unresectable Gastric Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
Gastric cancer (GC) is the fifth most commonly diagnosed cancer, with over one million cases diagnosed annually worldwide. Human epidermal growth factor receptor 2 (HER2) overexpression in GC (seen in 4.4% to 53.4% of patients in different reports) is predictive biomarker of response to HER2-targeting therapies. Trastuzumab in combination with cisplatin or oxaliplatin, and a fluoropyrimidine (capecitabine or 5-fluorouracil \[5-FU\]), is approved anti-HER2 therapy for first-line treatment of HER2-positive gastric or gastroesophageal junction (GEJ) cancer. Rilvegostomig 750 mg Q3W was selected as recommended Phase 2 dose based on all available ARTEMIDE-01 clinical safety, efficacy, PK, RO data as well as modeling analysis. The dose of 750 mg Q3W is predicted to achieve intra-tumoral RO of ≥ 90% in the majority of participants across a broad spectrum of conditions. This is a phase II study to initially assess the efficacy of perioperative Trastuzumab Deruxtecan (T-DXd) and Capecitabine combination with or without Rilvegostomig in patients with HER2 positive locally advanced unresectable GC and potentially by subsequent protocol amendment in HER2 low locally advanced GC. Other agents may also subsequently be assessed in this protocol, by protocol amendments . \---------------------------------------------------------------------------------------------------- Therefore, these studies provide robust evidence that immune checkpoint inhibitors plus chemotherapy, specifically the perioperative durvalumab plus FLOT regimen, can increase pCR rate and significantly improve long-term survival outcomes for patients with resectable gastric, GEJ, or esophageal cancer.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Zgoda na udział w badaniu.
- •Osoby powyżej 19 roku życia.
- •Przewidywany czas życia co najmniej 12 tygodni.
- •Rak żołądka lub połączenia przełyku z żołądkiem, który nie może być usunięty operacyjnie, z potwierdzonym zwiększonym HER2.
- •Ogólny stan zdrowia pozwalający na aktywność (ECOG 0-1).
- •Prawidłowa praca serca (LVEF ≥ 50%).
- •Choroba, którą można zmierzyć w badaniach obrazowych.
- •Wystarczająca ilość komórek krwi i dobra praca narządów (wątroby, nerek).
✗ Disqualifies
- •Obecność przerzutów do innych narządów.
- •Niewystarczająca wydolność narządów (np. wątroby, nerek).
- •Ciąża lub karmienie piersią.
- •Stosowanie pewnych innych leków przeciwnowotworowych w ostatnim czasie.
Simplified criteria — AI translation
Trial details
- Minimum age
- 19 Years
- Last updated (source)
- July 1, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Samsung Medical Center
Seoul, South Korea
Trial contact
Jeeyun Lee, Ph, MD
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.