A biomarker research of "CapeOX or SOX plus zolbetuximab in HER2-negative and CLDN18.2-positive unresectable advanced recurrent gastric or oesophagogastric junction cancer: Randomised, non-comparative phase II clinical trial JACCRO GC-12 (C-SOLVE trial)"

A biomarker research of "CapeOX or SOX plus zolbetuximab in HER2-negative and CLDN18.2-positive unresectable advanced recurrent gastric or oesophagogastric junction cancer: Randomised, non-comparative phase II clinical trial JACCRO GC-12 (C-SOLVE trial)" - JACCRO GC-12AR

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000056281

Enrollment

120

Registered

2024-11-27

Start date

2024-11-26

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

HER2-negative, CLDN18.2-positive unresectable advanced recurrent gastric or oesophagogastric junction cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients who meet all the eligibility criteria and none of the exclusion criteria for JACCRO GC-12 (C-SOLVE trial). (2) Among the cases consenting to participate in the JACCRO GC-12 (C-SOLVE) trial, those who have received a thorough explanation of the study details and have provided written informed consent.

Exclusion criteria

Exclusion criteria: (1) Cases in which the principal investigator determines that participation in this study is inappropriate. (2) Cases in which the subject did not consent to the use of his/her specimen for research purposes.

Design outcomes

Primary

Measure	Time frame
Associations between treatment efficacy and evaluated biomarkers.	—

Secondary

Measure	Time frame
Associations between adverse events and evaluated biomarkers. Changes in major biomarkers before, during, and after treatment discontinuation.	—

Countries

Japan

Contacts

Public ContactYohei Kubota

St. Marianna University School of Medicine Department of Clinical Oncology

ykubota@marianna-u.ac.jp044-977-8111

Outcome results