Real-WorlD ZolbetUximab in Patients With HER-2 Negative and CLaudin 18.2 PosItive MetastatiC AdEnocarcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorEuropean Institute of Oncology
About this trial
The primary objective is to validate, throughout a national real-world study, the efficacy and safety of Zolbetuximab combined with FOLFOX or XELOX regimens. Specific clinical issues will be studied by pre-planned subgroup analyses, addressing practical clinical needs which have not been specifically investigated in randomized clinical trials.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient with histologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.
Patient with locally advanced, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
Patient whose tumor expresses claudin18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous CLDN18 staining as determined by local or central immunohistochemistry testing.
Patient with a Human epidermal growth factor receptor 2 negative tumor by local testing on a gastric or gastroesophageal junction tumor specimen.
Disqualifiers
Patient has previously received treatment in a clinical trial of zolbetuximab, or a clinical trial that included zolbetuximab as 1 of the treatment options, even if the patient was not given zolbetuximab.
Patient has known dihydropyrimidine dehydrogenase deficiency.
Patient has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. However, patient may have received either neoadjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies as long as it was completed at least 6 months prior to participation.
Trial population
Adult patients (≥ 18 years) with advanced HER-2 negative and Claudin 18.2 positive gastric or gastroesophageal junction adenocarcinoma.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
70 Participants
are grouped into 1 trial groupGroup A: patient with unresectable or metastatic gastric adenocarcinoma.
Trial outcomes
Primary outcomes
1
Progression-free survival
The primary endpoint of this one-arm observational study is progression-free survival
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov