Efficacy of intraperitoneal immunotherapy with the trifunctional antibody catumaxomab in addition to systemic chemotherapy in patients with peritoneal carcinomatosis from colorectal or gastric cancer

ABSTRACT: Background and study aims Peritoneal carcinomatosis (PC) is a rare type of cancer that occurs in the peritoneum, the thin layer of tissue that covers abdominal organs and surrounds the abdominal cavity. PC that has spread from gastrointestinal tumours is associated with an average survival of only a few months. There is currently no standard treatment to prevent or eradicate. Various treatments have been tested including peritonectomy (surgery removing most of the peritoneum), or applying chemotherapy directly into the abdominal cavity (intraperitoneal), whether heated (hyperthermic intraperitoneal chemotherapy) or not. No effective treatment is available for patients with PC who are not eligible for surgery to remove the tumour. Chemotherapy has been used with only a small effect on preventing disease progression and symptoms. The aim of this study is t find out whether a two cycle intraperitoneal catumaxomab treatment in addition to standard intravenous chemotherapy (into a vein) is able to increase symptom and progression free survival. Who can participate? Patients aged 18 or over with peritoneal carcinomatosis from colorectal or gastric cancer who are not eligible for surgery What does the study involve? All participants are treated with intraperitoneal catumaxomab on day 0, 3, 7 and 10 after the start of treatment, followed by intravenous chemotherapy on days 30 to 90. This is followed by a second cycle of intraperitoneal catumaxomab between days 91 and 120, followed by intravenous chemotherapy between days 121 and 180. The study ends at day 270. There is an additional optional follow-up at 15 months.

DISEASE(S): Peritoneal Carcinomatosis From Colorectal And Gastric Cancer (adenocarcinoma)

PROVIDER: 2419416 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR