Evaluation, in Humans, of the Correlation Between Hepatotoxicity, Neurotoxicity Induced by Oxaliplatin, and Blood Levels of HMGB1

Launched by UNIVERSITY HOSPITAL, CLERMONT-FERRAND · Oct 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a chemotherapy drug called oxaliplatin on patients with certain types of cancers, specifically pancreatic and oesogastric cancers. Researchers want to understand how oxaliplatin may cause liver and nerve problems after treatment, which can make recovery more difficult. They believe that a protein called HMGB1 could be released after using oxaliplatin and may be linked to these complications. By finding a connection between HMGB1 levels and side effects, doctors hope to improve treatments and support for patients undergoing chemotherapy.

To be eligible for this study, participants must be adults aged 65 to 74 who have a specific type of cancer that can be surgically removed. They should be healthy enough to undergo a procedure called laparoscopy and be able to speak and understand French. Participants will receive standard chemotherapy treatments before and after surgery, and the study aims to collect information about their health and any side effects they experience. It’s important to note that individuals with certain health conditions or complications, such as liver failure or other serious illnesses, may not be eligible for this trial.

Gender

ALL

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