A multifaceted analysis for the elucidation of the pathophysiology of hypoalbuminemia occurring during zolbetuximab + chemotherapy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1031250843

Enrollment

Registered

2026-03-25

Start date

2026-03-25

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

unresectable advanced/recurrent CLDN18.2-positive gastric cancer or esophagogastric junction cancer

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1)Diagnosed with unresectable advanced/recurrent CLDN18.2-positive gastric cancer or esophagogastric junction cancer 2)Initiated on zolbetuximab + chemotherapy (mFOLFOX6, CAPOX or SOX) 3)Have not undergone surgical resection of the primary gastric tumor, regardless of whether radical or palliative (Gastrojejunostomy without primary tumor resection is permitted) 4)Obtained written informed consent 5)ECOG performance status of 0 to 2 6)Adequatel organ functions 7) Age=>18 years at the time of informed consent.

Exclusion criteria

Exclusion criteria: 1)Taking more than one antiplatelet agent, or unable to undergo an endoscopic biopsy because of a bleeding tendency or other medical conditions 2)History of invasive malignant carcinoma within five years prior to informed consent (note that patients with adequately treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, carcinoma in situ or lesions equivalent to intramucosal carcinoma treatable by local therapy are not considered to have active synchronous malignancies) 3)Active infection requiring systemic therapy 4)Deemed inappropriate for participation in this study by the principal investigator/sub-investigator

Design outcomes

Primary

Measure	Time frame
The association between RNA expression profiles in tumor and non-tumor tissues following zolbetuximab administration and hypoalbuminemia as well as associations between molecular profiles, such as plasma proteome and gut microbiota profiles and hypoalbuminemia	—

Secondary

Measure	Time frame
The association between RNA expression profiles in tumor and non-tumor tissues following zolbetuximab administration and clinicopathological factors, clinical course, and efficacy indices, as well as associations between molecular profiles, (such as plasma proteome and gut microbiota profiles) and clinicopathological factors, clinical course, and efficacy indices	—

Contacts

Public ContactKeitaro Shimozaki

Cancer Institute Hospital of Japanese Foundation for Cancer Research

keitaro.shimozaki@jfcr.or.jp+81-3-3520-0111

Outcome results