NCT01784900终止2 期
Treatment of Gastric Peritoneal Carcinomatosis by Association of Complete Surgical Resection of the Lesions and Intraperitoneal Immunotherapy Using Catumaxomab. A Randomized Phase II Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
Treatment by association of complete surgical excision of the lesions and intraperitoneal immunotherapy using Catumaxomab for patients with gastric peritoneal carcinomatosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
Schema B (140µg)
Experimental
- D0 : 20 μg of catumaxomab
- D2 : 40 μg
- D4 : 80 μg
干预措施: Catumaxomab 140µg (Drug)
Schema A (100µg)
Experimental
- D0 : 10 μg of catumaxomab
- D2 : 30 μg
- D4 : 60 μg
干预措施: Catumaxomab 100µg (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: every 3 months for the first two years
次要结局
- 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)
研究者
研究点 (1)
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