Randomized Phase II trial Evaluating the Efficacy of ZolbEtuximab in the second-line for CLaudin18.2 Positive AdvanceD GAstric/EGJ Cancer Patients Previously Treated with Zolbetuximab and Platinum-Based Chemotherapy (ZELDA trial):Translational Biomarker Research (ZELDA-TR trial)

Randomized Phase II trial Evaluating the Efficacy of ZolbEtuximab in the second-line for CLaudin18.2 Positive AdvanceD GAstric/EGJ Cancer Patients Previously Treated with Zolbetuximab and Platinum-Based Chemotherapy (ZELDA trial):Translational Biomarker Research (ZELDA-TR trial) - ZELDA-TR trial

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000059075

Enrollment

170

Registered

2025-10-01

Start date

2026-03-06

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

gastric cancer and esophagogastric junction (EGJ) cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects who have consented to the ZELDA study and who have provided their written consent for the study after receiving sufficient explanation regarding the content of this study.

Exclusion criteria

Exclusion criteria: (1) Subjects whose participation in this study is judged inappropriate by the investigator. (2) Subjects who did not consent to use their samples in the study.

Design outcomes

Primary

Measure	Time frame
Relationship between CLDN18.2 expression before the start of protocol treatment and therapeutic efficacy	—

Secondary

Measure	Time frame
Relationship between CAV-1 expression and its variation over time and therapeutic efficacy Relationship between CLDN18.2 expression and its variation over time and treatment course Relationship between CLDN18.2 expression and its variation over time and CLDN18-ARHGAP fusion Relationship between CLDN18.2 expression and plasma measurement factors that are measured Association of liquid-based DNA methylation signatures and liquid-based gene alterations with plasma proteins Association of liquid-based DNA methylation signature and liquid-based gene alterations that measures before treatment initiation with treatment response Association of liquid-based DNA methylation signatures that measures before treatment initiation and adverse events Association between liquid-based DNA methylation signatures before and during treatment initiation and liquid-based gene alterations Association between changes in plasma DNA methylation signature before and during treatment initiation and the course of treatment Comparison of liquid-based DNA methylation signatures, liquid-based gene alterations and plasma proteins measured over time to investigate resistance mechanisms	—

Measure

Time frame

Relationship between CAV-1 expression and its variation over time and therapeutic efficacy Relationship between CLDN18.2 expression and its variation over time and treatment course Relationship between CLDN18.2 expression and its variation over time and CLDN18-ARHGAP fusion Relationship between CLDN18.2 expression and plasma measurement factors that are measured Association of liquid-based DNA methylation signatures and liquid-based gene alterations with plasma proteins Association of liquid-based DNA methylation signature and liquid-based gene alterations that measures before treatment initiation with treatment response Association of liquid-based DNA methylation signatures that measures before treatment initiation and adverse events Association between liquid-based DNA methylation signatures before and during treatment initiation and liquid-based gene alterations Association between changes in plasma DNA methylation signature before and during treatment initiation and the course of treatment Comparison of liquid-based DNA methylation signatures, liquid-based gene alterations and plasma proteins measured over time to investigate resistance mechanisms

—

Countries

Japan

Contacts

Public ContactChiaki Inagaki

Kindai University Faculty of Medicine Department of Medical Oncology

chiaki_inagaki@med.kindai.ac.jp072-366-0221

Outcome results