2024-510768-21-00RecruitingPhase 2
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.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 1 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 203 (estimated)
- First submitted
- 18 Sept 2024
- Start date
- 16 Oct 2019
- Lead sponsor
- Academisch Ziekenhuis Leiden
- Diseases
- Colorectal cancer
- EU CT number
- 2024-510768-21-00
- EudraCT number
- 2019-001748-23
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 203
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or returning rectal cancer who are scheduled for surgery. It tests SGM-101, a dye-labeled antibody that helps show the cancer during the operation.
- Age
- Over 18 years
- Sex
- All sexes
- Disease stage
- Locally advanced rectal cancer (T3 with a threatened circumferential resection margin, or T4) or recurrent rectal cancer, scheduled for surgery.
- Earlier treatment
- Must not have had SGM-101 before.
Main reasons for not taking part
- Another cancer now or in the past 5 years (with a few exceptions)
- Cancer spread to the lining of the abdomen (peritoneal metastases)
- Clinically significant allergy
- Pregnant or breastfeeding
- Known positive test for HIV, hepatitis B or hepatitis C, or untreated serious infection
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous administration of SGM-101.
Other illness
- 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.
Lab values
- 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.
Other
- Patients pregnant or breastfeeding lack of effective contraception in male or female patients with reproductive potential.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Stichting | Amsterdam | Netherlands | Recruiting |
| Catharina Ziekenhuis Stichting | Eindhoven | Netherlands | Recruiting |
| Universitair Medisch Centrum Groningen | Groningen | Netherlands | Recruiting |
| Leids Universitair Medisch Centrum (LUMC) | Leiden | Netherlands | Recruiting |
| Haaglanden Medisch Centrum Stichting | Leidschendam | Netherlands | Recruiting |
| Radboud universitair medisch centrum Stichting | Nijmegen | Netherlands | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) | Rotterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.