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Open Access Highly Accessed Study protocol

Treatment of gastric peritoneal carcinomatosis by combining complete surgical resection of lesions and intraperitoneal immunotherapy using catumaxomab

Diane Goéré1*, Nathalie Gras-Chaput2, Anne Aupérin3, Caroline Flament2, Christophe Mariette4, Olivier Glehen5, Laurence Zitvogel2 and Dominique Elias1

Author Affiliations

1 Department of Surgical Oncology - Gustave Roussy, 114 rue Edouard Vaillant, Villejuif, Cedex 94805, France

2 Institut National de la Santé et de la Recherche Médicale, U1015, Gustave Roussy, 114 rue Edouard Vaillant, Villejuif, Cedex 94805, France

3 Department of Statistics - Gustave Roussy, 114 rue Edouard Vaillant, Villejuif, Cedex 94805, France

4 Department of Digestive and Oncological Surgery, University Hospital C. Huriez, Place de Verdun, Lille, Cedex 59037, France

5 Department of Surgical Oncology, Centre Hospitalier Lyon Sud, Pierre Bénite 69495, France

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BMC Cancer 2014, 14:148  doi:10.1186/1471-2407-14-148

Published: 4 March 2014

Abstract

Background

The peritoneum is one of the most frequent sites of recurrent gastric carcinoma after curative treatment, despite the administration of pre- and/or postoperative systemic chemotherapy. Indeed, the prognosis of peritoneal carcinomatosis from gastric carcinoma continues to be poor, with a median survival of less than one year with systemic chemotherapy. Whereas the prognosis of peritoneal carcinomatosis from colorectal cancer has changed with the development of locally administered hyperthermic intraperitoneal chemotherapy (HIPEC), survival results following carcinomatosis from gastric cancer remain disappointing, yielding a 5-year survival rate of less than 20%. Innovative surgical therapies such as intraperitoneal immunotherapy therefore need to be developed for the immediate postoperative period after complete cytoreductive surgery. In a recent randomised study, a clinical effect was obtained after intraperitoneal infusion of catumaxomab in patients with malignant ascites, notably from gastric carcinoma. Catumaxomab, a nonhumanized chimeric antibody, is characterized by its unique ability to bind to three different types of cells: tumour cells expressing the epithelial cell adhesion molecule (EpCAM), T lymphocytes (CD3) and also accessory cells (Fcγ receptor). Because the peritoneum is an immunocompetent organ and up to 90% of gastric carcinomas express EpCAM, intraperitoneal infusion of catumaxomab after complete resection of all macroscopic disease (as defined in the treatment of carcinomatosis from colorectal cancer) could therefore efficiently treat microscopic residual disease.

Methods/design

The aim of this randomized phase II study is to assess 2-year overall survival after complete resection of limited carcinomatosis synchronous with gastric carcinoma, followed by an intraperitoneal infusion of catumaxomab with different total doses administered in each of the 2 arms. Close monitoring of peri-opertive mortality, morbidity and early surgical re-intervention will be done with stopping rules. Besides this analysis, translational research will be conducted to determine immunological markers of catumaxomab efficacy and to correlate these markers with clinical efficacy.

Keywords:
Peritoneal carcinomatosis; Gastric carcinoma; Intraperitoneal chemotherapy; Immunotherapy; Catumaxomab