Dosing of Various Multikinase Inhibitors Plasma Levels in Advanced Digestive Cancer Patients to Determine Optimal Dose for Each Treatment

What this Trial Is About

Researchers are evaluating the plasma levels of various multikinase inhibitors in patients treated for advanced digestive cancers, including gastrointestinal stromal tumor, metastatic colorectal cancer, hepatocellular carcinoma, gastroenteropancreatic neuroendocrine tumor, and pancreatic neuroendocrine tumor. The study aims to determine the optimal drug dose for each patient in the future through detailed monitoring of drug concentrations. This is a Phase IV, national, multicenter, open, multi-cohort interventional study focused on improving personalized dosing strategies for these treatments. Participants are grouped by the specific treatment and cancer type they receive Regorafenib for metastatic colorectal cancer, gastrointestinal stromal tumor, and hepatocellular carcinoma Everolimus for gastroenteropancreatic neuroendocrine tumor Sunitinib for pancreatic neuroendocrine tumor and gastrointestinal stromal tumor Cabozantinib for hepatocellular carcinoma and the combination of Encorafenib and Cetuximab for metastatic colorectal cancer. Treatment and follow-up follow standard care guidelines, with blood samples collected at baseline, one month, two months after treatment start, during adverse events, and at disease progression to measure drug plasma levels. During the study, participants undergo blood sampling to assess drug concentrations and are monitored for disease progression and safety outcomes over up to four years. Researchers will evaluate trough drug concentrations as the primary outcome and track progression-free survival, overall survival, objective response rate, disease control rate, and drug toxicity as secondary outcomes. The study involves regular assessments and long-term follow-up to understand how drug levels relate to treatment response and safety.

TARGETed Therapy Drug MONITOring in DIGestive Oncology