Study of Oxaliplatin-Related Liver and Nerve Side Effects in Patients with Resectable Oesogastric and Pancreatic Adenocarcinomas Using Blood HMGB1 Levels

What this Trial Is About

Oesogastric and pancreatic adenocarcinomas are cancers with poor prognosis, and pancreatic cancer is expected to become the second leading cause of cancer death by 2030. This research aims to understand the biological processes involved in sinusoidal obstruction syndrome SOS, a liver condition triggered by oxaliplatin chemotherapy that increases post-operative complications and risks such as chemotherapy-induced peripheral neuropathy CIPN. The study explores the role of HMGB1, a protein suspected to mediate these toxic effects, to enable better prevention and treatment strategies. Participants will undergo routine laparoscopy and receive oxaliplatin-based chemotherapy FLOT, FOLFOX, or FOLFIRINOX before surgery to remove their tumors. Researchers will assess serum HMGB1 levels before and after chemotherapy and at surgery to investigate its correlation with SOS and CIPN development. The study involves measuring additional markers like RAGE and monitoring liver and neurological health throughout treatment. During the study, participants will have blood tests at exploratory laparoscopy, at the first and last chemotherapy cycles before surgery, and at surgery. SOS diagnosis and CIPN evaluation will occur before chemotherapy, after chemotherapy cycles, and following surgery, with follow-up extending up to 10 months. The primary outcome is the serum HMGB1 concentration at laparoscopy and surgery, helping researchers understand its predictive value for liver and nerve toxicities.

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