A Randomized Phase II Clinical Trial Evaluating the Safety and Efficacy of Initial Dose Adjustment of Zolbetuximab Plus Chemotherapy in Patients with HER2-negative and CLDN18.2-positive Unresectable Advanced or Recurrent Gastric, Gastroesophageal junction cancer or esophageal adenocarcinoma

A Randomized Phase II Clinical Trial Evaluating the Safety and Efficacy of Initial Dose Adjustment of Zolbetuximab Plus Chemotherapy in Patients with HER2-negative and CLDN18.2-positive Unresectable Advanced or Recurrent Gastric, Gastroesophageal junction cancer or esophageal adenocarcinoma - GENTLE-Z trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031240347

Enrollment

130

Registered

2024-09-20

Start date

2024-09-20

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

Interventions

Experimental therapy: Patients received zolbetuximab (400mg/m2) plus mFOLFOX6 every 2 weeks or zolbetuximab (600mg/m2) plus CapeOX every 3 weeks. Standard therapy: Patients received zolbetuximab (800m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Diagnosed as HER2-negative and CLDN18.2-positive locally advanced unresectable or metastatic gastric, gastro-oesophageal junction, or oesophageal adenocarcinoma. 2)No previous treatment of chemotherapy (One cycle of mFOLFOX6/CapeOX/SOX was acceptable). 3)Age 18 years or older on the date of consent. 4)ECOG PS of 0-2. 5)Ability to safely receive the protocol treatment. 6)Written informed consent obtained from the patient.

Exclusion criteria

Exclusion criteria: Judged ineligible for trial participation by the investigator.

Design outcomes

Primary

Measure	Time frame
vomiting free rate in the first cycle	—

Secondary

Measure	Time frame
Nausea free rate in the first cycle, Proportion of zolbetuximab dose interruption, Proportion of zolbetuximab resumption of treatment after interruption, Proportion of additional antiemetics in the first cycle, Progression-free survival, Overall survival, Objective response rate, Disease control rate, Adverse events	—

Contacts

Public ContactMashiro Okunaka

National Cancer Center Hospital East

mokunaka@east.ncc.go.jp+81-4-7133-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026