Treatment of Gastric Peritoneal Carcinomatosis by Association of Complete Surgical Resection of the Lesions and Intraperitoneal Immunotherapy Using Catumaxomab

• Status: Terminated
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Treatment by association of complete surgical excision of the lesions and intraperitoneal immunotherapy using Catumaxomab for patients with gastric peritoneal carcinomatosis

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Treatments: Antibodies, Bispecific; Catumaxomab

Criteria

Inclusion Criteria:

• consent form signed

• Age >= 18

• Carcinomatosis pre operative known or discivered in intraoperative

• Patients uin good general condition who may have extent surgery associated to specific inflammatory syndrom of immunotherapy

• Patients in good general condition

• Patient insured to social care

Inclusion Criteria (intraoperative):

• Gastric adenocarcinoma with macroscopic peritoneal carcinomatosis (PC) confirmed by extemporaneous histological examination

• CP extension minimal or moderate (peritoneal index ≤ 12).

• Resection of the entire macroscopic lesions detectable (primary tumor, lymph nodes and CP). cleaning D2 lymph node (or D1.5).

Exclusion Criteria:

• Presence of metastasis in reach

• Previous treatment with a non-humanized monoclonal AC- (mice or rat)

• Hypersensitivity to any type of antibody.

• History of cancer within 5 years preceding the entry in the trial other than basal cell skin carcinoma or in situ of the cervix,

• Patients already included in another clinical trial with experimental molecule

• Pregnant, or likely to be or breastfeeding, (Women of childbearing potential should have a pregnancy test (blood) negative 15 days before the date of the surgery) Using of a suitable method of contraception for patients of childbearing age during treatment. adequate contraception Methods includeare: an intrauterine device, hormonal contraception, condom use combined with a spermicide

• Persons deprived of liberty or Trust (including curatorship)

• Unable to undergo medical test for geographical, social or psychological.

Exclusion Criteria (intraoperative):

• Persistent peritoneal lesions visible to the end of the surgery

• Resection of the tail of the pancreas or pancreatic break (because no drainage post-op); break pleural (for K cardia)

• Presence of metastasis in reach during surgery (except for ovarian metastasis