NL-OMON56317招募中2 期
Multicenter, open-label, controlled, parallel arms clinical study on the performance of SGM-101, a fluorochrome-labeled anti-carcino-embryonic antigen (CEA) monoclonal antibody, for locally advanced or recurrent rectal cancer patients undergoing curative surgery. - SGM-101 in Locally Advanced and Recurrent Rectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 203
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patients aged over 18 years old;
- •2. All women of child bearing potential and all males must practice effective
- •contraception during the study and be willing and able to continue
- •contraception for at least 30 days after their last dose of study treatment.
- •3. Patients should be scheduled and eligible for surgery because of a clinical
- •diagnosis of T3 with a threatened CRM or T4 rectal cancer (locally advanced) or
- •recurrent rectal cancer. (UICC. TNM classification of diseases for oncology.
- •3rd ed. Geneva: World Health Organization; 2000)
- •4. Patients should be capable and willing to give signed informed consent
- •before study specific procedures.
排除标准
- •1. Other malignancies, either currently or in the past five years, except
- •adequately treated in situ carcinoma of the cervix and basal or squamous cell
- •skin carcinoma.
- •2. Patients with a history of, or recently diagnosed with, peritoneal
- •metastases (even those diagnosed during surgery)
- •3. Patient with a history of a clinically significant allergy.
- •4. Patients pregnant or breastfeeding lack of effective contraception in male
- •or female patients with reproductive potential;
- •5. Laboratory abnormalities defined as:
- •a. Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl
- •Transferase) or Alkaline Phosphatase levels above 5 times the or;
- •b. Total bilirubin above 2 times the ULN or;
- •c. Serum creatinine above 1.5 times the ULN or;
- •d. Platelet count below 100 x 109/L or;
- •e. Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);
- •f. 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;
- •6. Any condition that the investigator considers to be potentially jeopardizing
- •the patients* well-being or the study objectives.
- •7. Previous administration of SGM-101
研究者
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