SGM-LARRC: 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 cancerpatients undergoing curative surgery.
Key facts
- Where
- Amsterdam, Eindhoven, Groningen, Leiden, Leidschendam, Nijmegen és Rotterdam, HollandiaSee the 7 sites
- Phase
- 2. fázis
Where in Hollandia
- Amsterdam UMC StichtingAmsterdam, HollandiaTaking people
- Catharina Ziekenhuis StichtingEindhoven, HollandiaTaking people
- Universitair Medisch Centrum GroningenGroningen, HollandiaTaking people
- Leids Universitair Medisch Centrum (LUMC)Leiden, HollandiaTaking people
- Haaglanden Medisch Centrum StichtingLeidschendam, HollandiaTaking people
- Radboud universitair medisch centrum StichtingNijmegen, HollandiaTaking people
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, HollandiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Academisch Ziekenhuis Leiden
- Trial code
- EU 2024-510768-21-00
- Record updated
- 2024. október 1.
- Original description
The primary objective is based on the clinical benefit of FGOS combined with SGM-101 as the intraoperative imaging agent. The corresponding endpoint is the rate of patients with R0 resections.Read full original descriptionShow less
The primary objective is based on the clinical benefit of FGOS combined with SGM-101 as the intraoperative imaging agent. The corresponding endpoint is the rate of patients with R0 resections.
Inclusion: Patients aged over 18 years old; 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; 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); Patients should be capable and willing to give signed informed consent before study specific procedures.
Exclusion: Previous administration of SGM-101; 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; Patients with a history of, or recently diagnosed with, peritoneal metastases (even those diagnosed during surgery); Patient with a history of a clinically significant allergy; Any condition that the investigator considers to be potentially jeopardizing the patients’ well-being or the study objectives; 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; Patients pregnant or breastfeeding lack of effective contraception in male or female patients with reproductive potential.