NIPH Clinical Trials Search

OGSG2501:A phase II trial of Zolbetuximab plus chemotherapy for Claudin 18.2-positive gastric cancer early relapsed during or after adjuvant chemotherapy(Z-FIGHTERS Study)

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Gastric cancer, Esophageal cancer
Date of first enrollment	31/10/2025
Target sample size	48
Countries of recruitment
Study type	Interventional
Intervention(s)	CAPOX + zolbetuximab Every 3 weeks Zolbetuximab: 800 mg/m2 (1st course) Day1 600 mg/m2 (after 2nd course) Day1 Oxaliplatin: 130 mg/m2 IV (2 hours) Day1 Capecitabine: 1000 mg/m twice daily Day 1-14 The above is repeated every 3 weeks until the protocol discontinuation criteria are met. FOLFOX + zolbetuximab Every 2 weeks Zolbetuximab: 800 mg/m2 (1st course) IV Day1 400 mg/m2 (after 2nd course) IV Day1 Levofolinate: 200 mg/m2 IV (2 hours) Day1 Oxaliplatin: 85 mg/m2 IV (2 hours) Day1 Fluorouracil: 400 mg/m2 IV (rapid IV infusion) Day1 Fluorouracil: 2400 mg/m2 IV (46 hours continuous IV infusion) Day1 The above is repeated every 2 weeks until protocol discontinuation criteria are met.

Outcome(s)

Primary Outcome	Progression-free survival by central review
Secondary Outcome	Progression-free survival assessed by investigators, Overall survival, Time to treatment failure, Objective response rate, Disease control rate, Safety

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1) Histologically diagnosed adenocarcinoma of the stomach or esophagogastric junction 2) confirmed gross radical resection and pathological Stage II or III (ypStage 0-III in cases of neoadjuvant chemotherapy), with adjuvant chemotherapy with S-1 or docetaxel + S-1(DS) (although preoperative treatment regimens are not specified, Postoperative treatment is limited to S-1 or DS therapy). 3) Patients with early post-operative recurrence (recurrence during adjuvant chemotherapy*** or within 6 months*** after completion of adjuvant chemotherapy). 4) Age 18 years or older at the time of enrolment. 5) ECOG PS 0 or 1 6) Histologically confirmed positive for claudin 18.2 7) Histologically confirmed HER2 negative (IHC 0, 1+ or 2+ and ISH negative) 8) Available for oral intake 9) With image-assessable lesions (measurable or non-measurable lesions according to RECIST version 1.1) 10)Has not previously received zolbetuximab 11)No prior treatment with chemotherapy or radiotherapy for recurrent gastric cancer 12)Written consent has been obtained from the subject himself/herself after a full explanation of the study content has been given prior to enrolment in the study 13) Clinical examination within 14 days prior to enrolment meets the following criteria. (The most recent data within 14 days of the date of enrolment are used for enrolment. Based on the date of registration, the same day of the week two weeks earlier is acceptable) Neutrophil count: or more 1500/mm3 Hemoglobin: or more 9.0 g/dL Platelet count: or more 10 x 104/mm3 AST, ALT: or less 100 IU/L (or less 200 IU/L if liver metastases are present) Total bilirubin: or less 1.5 mg/dL (except Grade 1 hyperbilirubinemia due to Gilbert's syndrome) Creatinine: or less 1.5 mg/dL or creatinine clearance or more 30 mL/min (Cockcroft-Gault estimation formula or 24-hour urine storage) * During adjuvant chemotherapy: after the start of the first course (with a history of at least one dose of S-1). ** After completion of adjuvant therapy: 6 weeks after the start of the last course as the end date of adjuvant therapy. *** Recurrence within 6 months: after 6 weeks from the start of the last course of treatment for the convenience of the center or the subject. Recurrence after 6 months but within 4 weeks of examination is acceptable.
Exclude criteria	1) The patient has active overlapping carcinoma (simultaneous overlapping carcinoma and iatrogenic overlapping carcinoma with a disease-free period of 5 years or less. However, carcinoma in situ (intraepithelial carcinoma) and intramucosal carcinoma equivalent lesions that are considered curable by local treatment are not included in active overlapping carcinoma). 2) Symptomatic interstitial pneumonia or pulmonary fibrosis is present. 3) Infections requiring systemic treatment (however, HBsAg-positive patients may be enrolled if they are controlled with nucleic acid analogs and confirmed HBV DNA negative)*1 4) Have a fever of 38 degrees Celsius or higher at the time of enrollment. 5) Women who are pregnant, lactating, may be pregnant or intend to become pregnant. Males whose partners wish to become pregnant. 6)Psychosis or psychiatric complications that make participation in the study difficult. 7)Has serious complications 8)Have symptoms of suspected metastasis to the central nervous system (brain, spinal cord, meninges) 9)Have Grade 2 or higher nausea, vomiting, or peripheral sensory neuropathy 10)Undergoing blood transfusion therapy within 2 weeks prior to enrollment 11)Has undergone surgery within 2 weeks prior to enrollment 12)Preoperatively treated patients are diagnosed as cStage IVB before preoperative treatment 13) Patient has massive ascites effusion 14) Symptomatic pleural effusion requiring drainage 15) Enrolled in another interventional trial at the time of enrollment 16) Other conditions deemed inappropriate by the principal investigator or subinvestigator 1 Measurement of HBs antibody, HBc antibody, and HBV DNA will be in accordance with the Hepatitis B Treatment Guidelines.