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A Phase II Clinical Trial Evaluating the Antiemetic Effect and Safety of a Five-Drug Combination Therapy for Zolbetuximab, Including Olanzapine and Antihistamines, with or without Pre-Treatment Olanzapine (OPTIMIZE:WJOG19524G)

A Phase II Clinical Trial Evaluating the Antiemetic Effect and Safety of a Five-Drug Combination Therapy for Zolbetuximab, Including Olanzapine and Antihistamines, with or without Pre-Treatment Olanzapine (OPTIMIZE:WJOG19524G)

Yamamoto Nobuyuki

Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN

wjog@wjog.jp

Takeda Koji

West Japan Oncology Group

Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN

+81-6-6633-7400

datacenter@wjog.jp

Recruiting

Oct. 31, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1) Unresectable, advanced, or recurrent gastric or gastro-oesophageal junction cancer.
2) HER2-negative and CLDN18-positive
3) Scheduled to receive zolbetuximab plus chemotherapy (a fluoropyrimidine and oxaliplatin doublet regimen).
4) No prior administration of zolbetuximab or CLDN18.2-targeted therapeutic agents.
5) Age 18 years or older on the date of informed consent.
6) ECOG PS 0-2.
7) No severe impairment of major organs and meets laboratory criteria.
8) Prior to enrolment in this trial, the patient has received a thorough explanation of the trial content and has provided written informed consent.

1) The presence of symptoms such as nausea or vomiting.
2) Presence of symptomatic brain metastases or meningeal dissemination.
3) Diabetes mellitus that contraindicates olanzapine administration.
4) Inability to take olanzapine orally.
5) Plans to take prescribed medications.
6) Presence of a psychiatric disorder that would make participation in this trial difficult.
7) Any other conditions deemed inappropriate by the attending physician.

Both

HER2-negative and CLDN-positive unresectable advanced recurrent gastric or gastro-oesophageal juncti

Previous day pre-sleep olanzapine non-administration group
5-HT3 receptor antagonist + steroid + NK1 receptor antagonist + antihistamine + olanzapine (placebo on day 0 before sleep + active drug 5 mg on days 1-4)
Previous day pre-sleep olanzapine administration group
5-HT3 receptor antagonist + steroid + NK1 receptor antagonist + antihistamine + olanzapine (active drug 5 mg on day 0 before bedtime + active drug 5 mg on days 1-4)

HER2-negative,CLDN-positive,unresectable advanced recurrent gastric or gastro-oesophageal juncti

Previous day pre-sleep olanzapine non-administration ,Previous day pre-sleep olanzapine administration

The percentage of cases of vomiting that were controlled by the investigator's judgement throughout the entire first course.

Complete response rate, complete control rate, and total control rate during the acute phase, late phase, and entire treatment period of the first course
Nausea, vomiting, and anorexia during the second and third courses
Rescue therapy
Maximum infusion speed of Zolbetuximab, presence or absence of infusion interruption or discontinuation, and total infusion time during courses 1-3
Adverse events
Patient-reported outocome of nausea and vomiting

+81-52-762-6111

Sept. 02, 2025

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