Study in Patients With Peritoneal Carcinomatosis From CEA Overexpressing Digestive Cancer (NCT02784028) | Clinical Trial Compass
CompletedNot Applicable
Study in Patients With Peritoneal Carcinomatosis From CEA Overexpressing Digestive Cancer
France18 participantsStarted 2014-12
Plain-language summary
The digestive cancer is the second cause of death worldwide. The presence of peritoneal carcinomatosis is common in the evolution of this type of cancer, as well as increased levels of ACE. This peritoneal carcinomatosis is often underestimated, this being due to low sensitivity detection means.
In recent years, it has been shown that peritoneal carcinomatosis surgery as complete as possible associated with an intraperitoneal chemotherapy gave better results but still failures associated with the presence of microscopic residual tumors.
The use of SGM -101 (developped by SURGIMAB SAS) allows surgeons to detect tumor nodules of small size very easily, in real-time, during surgery (shown in animals).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Cytologically or histologic proven primary or recurrent digestive adenocarcinoma and eligible for hyperthermic intraperitoneal chemoperfusion (HIPEC) procedure,
. Evidence of peritoneal carcinomatosis, presume resectable, assessed by imaging (CT scan (Computed Tomography Scanner) and / or MRI (Magnetic Resonance Imaging)) or during a previous abdominal surgery,,
. CEA positivity by immunohistochemistry on specimen of primary tumor or recurrence lesion, or circulating plasma CEA ≥ 2 times the upper limit of normal range (ULN),
. ECOG (Eastern Cooperative Oncology group) \< 1
. Life expectancy of at least three months,
. AST (Aspartate AminoTransferase), ALT (Alanine AminoTransferase) and Alkaline Phosphatase levels ≤ 5 times the ULN,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose (MTD)
Timeframe: 18 months
Trial details
NCT IDNCT02784028
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle
. Total bilirubin ≤ 1.5 times the ULN, Serum creatinine ≤ 1.5 times the ULN, absolute neutrophils counts ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L and hemoglobin ≥ 9 g/dL,(red blood transfusion is allowed if needed),
. Patients aged over 18 years old,
Exclusion criteria
. ASA (American Society of Anesthesiologists) score ≥ 3,
. Anticancer therapy (e.g. chemotherapy, radiotherapy, targeted therapy, concomitant systemic immune therapy, or any experimental therapy) within 4 weeks before inclusion,
. Known serious immune allergic history,
. Rate of circulating plasma CEA ≥ 300 ng / ml,
. 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.
. Female patients pregnant or breastfeeding (pregnancy should be ruled by an assay of βhCG plasma within 7 days prior to administration of the conjugate). Patients with reproductive potential and who are sexually active must agree to have at least two methods of contraception for the duration of treatment (2 weeks before and 8 12 weeks after the administration of SGM-101) Male patients, must use an effective method of contraception (condom with spermicidal foam or gel; true abstinence; or vasectomy throughout the study and up to 12 weeks after last SGM-101 administration).
. 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,
. Any other concurrent and/or uncontrolled medical condition or metabolic dysfunction, that would, in the investigator's judgment contraindicate her participation in the clinical study