Multicenter, semi-blinded, randomized, controlled, parallel arms clinical study on the performance of SGM-101, a fluorochrome-labeled anti- carcino-embryonic antigen (CEA) monoclonal antibody, for the delineation of primary and recurrent tumor and metastases in patients undergoing curative surgery for colorectal cancer. - NA

SURGIMAB0 个研究点目标入组 300 人开始时间: 2021年6月18日最近更新: 2024年1月8日

适应症

试验速览

暂无简介。

•1.Patients aged over 18 years old;
•2.Patients should be scheduled for curative colorectal cancer surgery of primary cT4 colon cancer or primary cT3/4 rectal cancer, recurrent colorectal cancer or peritoneal metastasized colorectal cancer;
•3.Female patients should not be of child-bearing potential (i.e., women with functioning ovaries who have a documented tubal ligation or hysterectomy, ovariectomy or women who are post-menopausal) nor breastfeeding. Women of child-bearing potential will be included provided that they have a negative urine pregnancy test at the day of the injection and agree to practice adequate contraception for 30 days prior to administration of investigational product, and 30 days after completion of injection;
•4.Patients should be capable and willing to give informed consent before study specific procedures.
•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 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 150

•1.Other malignancies, either currently active or diagnosed in the last 5 years, except for adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma;
•2.Primary appendiceal cancer;
•3.Laboratory abnormalities defined as:
•-Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the ULN or;
•-Total bilirubin above 2 times the ULN or;
•-Serum creatinine above 1.5 times the ULN or;
•-Platelet count below 100 x 109/L or;
•-Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);
•4.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
•5.Use of any investigational drug within 4 weeks of the Injection Day.
•6.Any condition that the investigator considers it would potentially jeopardize the patient’s well-being or the study objectives, such as severe anaphylactic reaction in medical history, previous allergic reaction to SGM-101 or to any excipient present in the product or known hypersensitivity to murine proteins.

发起方

SURGIMAB