EUCTR2013-000560-28-NO进行中（未招募）1 期
PHASE I/II TRIAL OF MOC31PE IMMUNOTOXIN IN PERITONEALCARCINOMATOSIS FROM COLORECTAL CARCINOMA.
Oslo University Hospital0 个研究点开始时间: 2014年12月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Histologically verified EpCAM positive peritoneal carcinomatosis from
- •colorectal cancer
- •- Ambulatory with ECOG performance status 0-1 at the time of surgery
- •- At least 18 years of age
- •- Isolated PC upon radiological work-up.
- •- Complete cytoreduction at surgery and mitomycin C given as standard
- •HIPEC procedure
- •- PCI =20
- •- Laboratory values:
- •- ANC >= 1.5 x 109/L
- •- Platelets >= 100 x 109/L
- •- Hb >= 9g/dL
- •- Creatinine <= 2x upper limit of normal
- •- Bilirubin < 2.0x the upper limit of normal
- •- ASAT and ALAT <= 2. 5x the upper limit of normal
- •- Albumin levels > 30 g/L
- •- INR<1.3
- •- Signed informed consent and expected cooperation with respect to
- •treatment and follow-up must be obtained and documented according to
- •ICH GCP, and national/local regulations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •- Other synchronous metastatic lesions. Patients may be included if they
- •have had curative resection of metastatic CRC disease more than 2 years
- •prior to inclusion and have no relapse at this location is detected.
- •- History of prior other malignant disease the last 3 years, except for
- •adequately treated carcinoma of the cervix or basal or squamous cell
- •skin cancer.
- •- History of CNS or bone metastases
- •- Significant cardiac or other medical illness that would limit activity or
- •survival, such as severe congestive heart failure, unstable angina, or
- •serious cardiac arrhythmia
- •- Chemotherapy/radiation therapy or major surgery within the last 4
- •weeks before start of treatment
- •- BMI > 35
- •- Any reason why, in the opinion of the investigator, the patient should
- •not participate in the study protocol
研究者
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