NL-OMON47359已完成不适用
A Phase I Study Assessing the Safety and Performance of SGM-101, a Fluorochrome-Labeled Anti-Carcinoembryonic Antigen Monoclonal Antibody for the Intraoperative Detection of Neoplastic Lesions in Patients with Cancer of the Colorectum or Pancreas - Phase I of SGM-101 in patients with cancer of the colorectum or pancreas
Surgimab0 个研究点目标入组 85 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patients aged over 18 years old;
- •2. Patient should be scheduled and eligible for surgery because of a clinical diagnosis of cancer of the colon rectum or cancer of the pancreas;
- •3. Both pancreatic and colorectal cancer patients: Circulating plasma CEA * the upper limit of normal range (eg * 3.0 ng / ml);
- •Patient suffering from recurrences and metastasis of colorectal cancer: Rising circulating plasma CEA);
- •4. Patients should be capable and willing to give informed consent before study specific procedures.
排除标准
- •1. Anticancer therapy (e.g. chemotherapy, radiotherapy (except for routine pre-operative radiotherapy in rectal cancer), targeted therapy, concomitant systemic immune therapy, or any experimental therapy) within 4 weeks before inclusion;
- •2. History of a clinically significant allergy;
- •3. Circulating plasma concentration CEA * 300 ng / ml;
- •4. Other malignancies either currently active or diagnosed in the last 5 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma;
- •5. Patients pregnant or breastfeeding (pregnancy should be ruled out by an assay of *hCG plasma within two weeks prior to administration of the conjugate), lack of effective contraception in male or female patients with reproductive potential;
- •6. Laboratory abnormalities defined as:
- •Rectal cancer patients only:
- •* Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or;
- •* Total bilirubin above 2 times the ULN or;
- •Both pancreatic and colorectal cancer patients:
- •* Serum creatinine above 1.5 times the ULN or;
- •* Absolute neutrophils counts below 1.5 x 109/L or;
- •* Platelet count below 100 x 109/L or;
- •* Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males).
- •7. Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody or patients with untreated serious infections;
- •8. Any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives.
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