Monitoring Blood Levels of Targeted Multi-Kinase Inhibitor Drugs in Adults With Advanced Digestive Cancers to Find the Best Dose

What this Trial Is About

Researchers are evaluating the plasma levels of various multikinase inhibitors MKIs in patients with advanced digestive cancers such as gastrointestinal stromal tumor GIST, metastatic colorectal cancer mCRC, hepatocellular carcinoma HCC, gastroenteropancreatic neuroendocrine tumor gepNET, and pancreatic neuroendocrine tumor pNET. This Phase IV, national, multicenter, open-label, multi-cohort interventional study aims to determine the optimal dose of these MKIs for each patient in the future. Participants receive treatment according to standard care for their specific cancer and MKI drug Regorafenib for mCRC, GIST, and HCC Everolimus for gepNET Sunitinib for pNET and GIST Cabozantinib for HCC and the combination of Encorafenib and Cetuximab for mCRC. Blood samples are collected at baseline, one month, and two months after treatment starts, as well as during adverse events or if disease progresses, to measure drug plasma concentrations and build pharmacokinetic models. During the study, participants are monitored through blood draws and tumor evaluations following local clinical practice. Researchers measure trough drug concentrations throughout treatment, along with progression-free survival, overall survival, response rates, disease control, and safety including drug toxicity for up to four years. This long-term follow-up helps understand treatment effects and drug exposure in advanced digestive cancer patients.

TARGETed Therapy Drug MONITOring in DIGestive Oncology