NCT06649474 Evaluation, in Humans, of the Correlation Between Hepatotoxicity, Neurotoxicity Induced by Oxaliplatin, and Blood Levels of HMGB1
| NCT ID | NCT06649474 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Clermont-Ferrand |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-09-06 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-09-06 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Oesogastric and pancreatic adenocarcinomas are poor-prognosis cancers. Incidence of pancreatic cancer drastically increases to such an extent that it will become the second cause of cancer's mortality by 2030. A major challenge is to optimize the therapies for localized setting, when oxaliplatin-based chemotherapy is the standard, before and after surgical excision. Because in 50% of cases oxaliplatin triggers a grade 2-3 sinusoidal obstruction syndrome (SOS) which increases post-operative morbidity, decreases histological response to chemotherapy, increases tumor recurrence, and aggravates the risk of chemotherapy-induced peripheral neuropathy (CIPN). There is an urgent need to better understand the biological processes involved in SOS, in order to prevent and treat it without stopping or reducing oxaliplatin administration. The biological link between oxaliplatin and SOS has not been described, but recent murine experiments argue for HMGB1 to be the mediator released after exposure to oxaliplatin and inducing SOS, and thereafter CIPN. To date, no biomarker is established between murine and patient analyses, and the release of HMGB1 after oxaliplatin treatment and its effect on hepatic parenchyma is not described in patients. Investigators hypothesized is that HMGB1 would also been increased in patients after oxaliplatin treatment, and correlated to the development of SOS and CIPN. If confirmed, personalized treatment will be possible to target this pathway. Therefore, investigators propose to dynamically explore this hypothesis in localized oesogastric and pancreatic cancer patients who will be routinely managed by an initial laparoscopy and post-oxaliplatin surgical excision.
Eligibility Criteria
Inclusion Criteria: * ECOG WHO Performance status = 0 or 1 * Signed and dated informed consent * Patients with histological diagnosis of oesogastric or pancreatic adenocarcinoma * Resectable tumors * Patients able to have a laparoscopy * In case of absence of peritoneal invasion on the laparoscopy, patient candidate to a chemotherapy schedule by FLOT or FOLFOX in perioperative setting for oesogastric adenocarcinoma, or FOLFIRINOX in perioperative setting for pancreatic adenocarcinoma * Registration in a national health care system (CMU included) * Patient speak and understand the french Exclusion Criteria: * Histology other than adenocarcinoma * Metastatic disease * History of previous treatment with oxaliplatine * History of systemic chemotherapy administration within 5 years prior to inclusion, * Patient with an non balanced progressive condition/disease (liver failure, renal failure (creatinine clearance \<30mL/min), respiratory failure, congestive heart failure, myocardial infarction in the last 6 months, etc.), * Patient on curative dose anticoagulant, * Patient with complete dihydropyrimidine dehydrogenase deficiency (Uracilemia ≥ 150 ng/ml), * Patient not operable for the pathology concerned, * Pregnant or breastfeeding woman, woman of childbearing age who has not performed a pregnancy test before the procedure, * Patient with legal incapacity (person deprived of liberty or under curatorship, stutorship, safeguard of justice), * Patient who, for psychiatric, social, family or geographical reasons, cannot be followed and/or comply with the requirements of the study,, * Discovery of peritoneal invasion during the peritoneal exploratory of the laparoscopy
Contact & Investigator
Marine JARY, MD
PRINCIPAL INVESTIGATOR
CHU Estaing de Clermont Ferrand/FRANCE
Frequently Asked Questions
Who can join the NCT06649474 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06649474 currently recruiting?
Yes, NCT06649474 is actively recruiting participants. Contact the research team at mjary@chu-clermontferrand.fr for enrollment information.
Where is the NCT06649474 trial being conducted?
This trial is being conducted at Clermont-Ferrand, France.
Who is sponsoring the NCT06649474 clinical trial?
NCT06649474 is sponsored by University Hospital, Clermont-Ferrand. The principal investigator is Marine JARY, MD at CHU Estaing de Clermont Ferrand/FRANCE. The trial plans to enroll 100 participants.
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