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

JRCT ID: jRCTs031240347

Registered date:20/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastric cancer
• Date of first enrollment: 20/09/2024
• Target sample size: 86
• Study type: Interventional

Intervention(s)

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 (800mg/m2 for cycle1, 400mg/m2 for subsequent cycles) plus mFOLFOX6 every 2 weeks or zolbetuximab (800mg/m2 for cycle1, 600mg/m2 for subsequent cycles) plus CapeOX every 3 weeks.

Outcome(s)

• Primary Outcome: vomiting free rate in the first cycle
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Diagnosed as 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.

• Exclude criteria: Judged ineligible for trial participation by the investigator.

Related Information

• Primary Sponsor: Nakayama Izuma
• Secondary Sponsor: Shitara Kohei