Safety Study of TrifluridineTipiracil Combined With Oxaliplatin for First-Line Treatment of Metastatic Colorectal or Gastroesophageal Cancer in Patients With DPD Deficiency

What this Trial Is About

Researchers are evaluating the safety of using trifluridinetipiracil as a replacement for fluoropyrimidine-based chemotherapy in patients with dihydropyrimidine dehydrogenase DPD deficiency who have metastatic colorectal or gastroesophageal cancer. This phase II trial aims to determine if this alternative chemotherapy is safer and whether combining it with other treatments improves progression-free survival, overall survival, response rates, disease control, and quality of life. Participants will receive trifluridinetipiracil orally along with oxaliplatin intravenously every 14 days. Depending on tumor type, they may also receive panitumumab or bevacizumab for colorectal cancer, or nivolumab or trastuzumab for gastroesophageal cancer. Treatments are given in cycles every two weeks, and the trial includes different combinations based on cancer biomarkers. During the study, participants will have CT scans every two months to monitor disease progression. They will complete quality of life questionnaires at baseline and every two months for up to six months. Optional blood samples will be collected for genetic and pharmacokinetic research. The primary outcome is treatment-specific safety measured within one month, with secondary outcomes including overall safety, treatment compliance, survival rates, tumor response, and quality of life assessments over up to two years.

Safety of Trifluridine/Tipiracil in Patients With Dihydropyrimidine Dehydrogenase Deficiency Diagnosed With Metastatic Colorectal or Gastroesophageal Cancer