Intraperitoneal Immunotherapy With The Bispecific Anti-Epcam X Anti-Cd3 Directed Antibody Catumaxomab For Patients With Peritoneal Carcinomatosis From Gastric Cancer: Final Results Of A Randomized Phase Ii Aio Trial.

4Background: The peritoneal surface is a common location for metastases in gastric cancer (GC). Intraperitoneal (i.p.) application of the bispecific (anti-EpCAM/CD3) monoclonal antibody catumaxomab (CATU) in addition to i.v. chemotherapy may improve elimination of peritoneal carcinomatosis (PC). Methods: This randomized open-label phase II study aimed to investigate the efficacy of i.p. CATU following i.v. chemotherapy in patients (pts) with GC and PC (Gilly stages P1-4). Pts were randomly allocated to receive four cycles of FLOT (5FU, LV, Oxaliplatin, Docetaxel) followed by i.p. CATU at escalating doses (10, 20, 50, 150µg) on days 0, 3, 7, 10 or FLOT alone. Secondary gastrectomy and peritonectomy were allowed to achieve complete resection of all malignant lesions. The primary endpoint was to show an increased rate of macroscopic complete remission of PC at second-look surgery. Secondary endpoints included toxicity, progression-free and overall survival (PFS/OS). Results: Of 35 pts screened, 31 were enrol...