Raltitrexed in HIPEC

All patients with CRC-PM who underwent CRS at the Department of Colorectal Surgery, Fudan University Shanghai Cancer Center between September 2020 and November 2024 were enrolled as part of the classical 3+3 dose-escalation phase I trial, and within a later expansion cohort. Initially, 3 patients were sequentially evaluated for DLTs at each dose level. The MTD was defined as the highest dose in cohorts where fewer than two of six evaluable patients experienced a DLT. Thereafter, additional patients were enrolled in an expansion cohort to determined the recommended phase II dose (RP2D). The RP2D was selected based on the DLT-defined MTD and the overall safety, tolerability, and supportive PK findings, and was further characterized in an expansion cohort at the candidate dose. The RTX-HIPEC protocol used the classical 3+3 dose escalation method with 7 dose levels (3, 4, 5, 6, 7, 8, 9 mg/m2).