Zolbetuximab, Durvalumab, and FLOT Combination Neoadjuvant Chemotherapy for CLDN18.2-Positive Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
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
Claudin 18.2 (CLDN18.2) is a molecular target expressed in a subset of gastric and gastroesophageal junction (GEJ) adenocarcinomas. Zolbetuximab, a chimeric monoclonal antibody targeting CLDN18.2, has shown clinical benefit in combination with chemotherapy for CLDN18.2-positive unresectable advanced or recurrent gastric cancer, and in Japan, FLOT plus durvalumab is expected to become a standard perioperative treatment for locally advanced gastric/GEJ adenocarcinoma. This trial evaluates whether adding zolbetuximab to FLOT plus durvalumab further improves the pathological response of neoadjuvant chemotherapy in CLDN18.2-positive, locally advanced, resectable gastric or GEJ adenocarcinoma. This is a single-arm, open-label, multicenter, investigator-initiated phase II trial conducted at four sites in Japan. Eligible participants are adults (18 years or older) with previously untreated (no prior chemotherapy, radiotherapy, or immunotherapy), histologically confirmed gastric or GEJ adenocarcinoma classified as cT2-4 and/or cN+, M0 by the UICC/TNM Classification (8th edition), confirmed to be CLDN18.2-positive (moderate or greater membranous staining in 75% or more of tumor cells) by immunohistochemistry, with an ECOG performance status of 0 or 1. The primary endpoint is the histological complete response rate (Grade 3) on the surgical specimen, assessed by a central pathological review committee. Key secondary endpoints include the incidence of adverse events, the treatment completion rate through surgery, the dose intensity of neoadjuvant chemotherapy, the R0 resection rate, and the histological response rate (Grade 2 or higher).
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony histologicznie rak żołądka lub połączenia przełyku ze żołądkiem
- •Brak wcześniejszej chemioterapii, radioterapii lub immunoterapii
- •Nowotwór wykazujący cechy CLDN18.2 (dodatni w co najmniej 75% komórek)
- •Brak przerzutów odległych (sprawdzonych tomografią)
- •Wiek 18 lat lub więcej
- •Dobry stan ogólny (skala ECOG 0-1)
- •Pisemna zgoda na udział w badaniu
✗ Disqualifies
- •Znaczne krwawienie lub zwężenie żołądka spowodowane nowotworem
- •Poprzednia immunoterapia blokerami punktów kontrolnych
- •Zaburzenia wyników badań laboratoryjnych uniemożliwiające uczestnictwo
- •Kobiety w ciąży lub karmiące piersią
- •Niespełnienie wymogów dotyczących antykoncepcji (dla kobiet w wieku rozrodczym i mężczyzn)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 14, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (4)
Saitama Cancer Center
Saitama, Japan
National Cancer Center Hospital
Tokyo, Japan
The Cancer Institute Hospital of JFCR
Tokyo, Japan
Kanagawa Cancer Center
Yokohama, Japan
Trial contact
Hirokazu Shoji, M.D., Ph.D.
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/15/2026.
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