Multicenter, Open-Label and Randomized Phase II Study to Evaluate Safety and Efficacy of the Trifunctional Bispecific Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) in Patients After Curative Resection of a Confirmed Gastric Adenocarcinoma Compared With Surgery Alone
A controlled, randomized, open-label, multi-center, parallel-group, Phase II study to
generate valid hypotheses on safety and efficacy issues in patients with a primary confirmed
diagnosis of gastric adenocarcinoma and a high risk of disseminated tumor cells due to
serosal infiltration after curative gastrectomy. Eligible patients will be centrally
randomized by IVRS during operation to one of the two study groups in an 1:1 ratio: surgery
plus catumaxomab or surgery alone.
Treatment with catumaxomab will consist of an initial dose of 10 µg given intraoperatively
as an intraperitoneal bolus on day 0 and of four following ascending doses (10-20-50-150 µg)
which will be administered as an i.p.-infusion via a provided indwelling catheter on the
days 7, 10, 13 and 16, respectively.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
safety and efficacy data
Marcus Heiss, Prof. Dr.