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

Treatment of Gastric Peritoneal Carcinomatosis by Association of Complete Surgical Resection of the Lesions and Intraperitoneal Immunotherapy Using Catumaxomab. A Randomized Phase II Trial.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01784900

Acronym

IIPOP

Enrollment

Registered

2013-02-06

Start date

2012-11-30

Completion date

2016-01-31

Last updated

2017-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients With Gastric Peritoneal Carcinomatosis

Brief summary

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

Interventions

DRUGCatumaxomab 100µg

DRUGCatumaxomab 140µg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Progression Free Survival	every 3 months for the first two years

Secondary

Measure	Time frame
Progression Free Survival	every 3 months for the first two years then every 4 months on year 3 then every 6 months on year 4 and 5

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026