Intraperitoneal paclitaxel combined with FOLFOX/CAPOX plus bevacizumab for colorectal cancer with peritoneal carcinomatosis (the iPac-02 trial): study protocol of a single arm, multicenter, phase 2 study.

"Declarations Conflict of interestThe authors declare no conflict of interest. Conflict of interest The authors declare no conflict of interest."

"Funding Open access funding provided by The University of Tokyo. This research is funded by the University of Tokyo Hospital and supported in part by crowdfunding through the UTokyo Foundation."

"A total of 38 patients will be enrolled in the study. The number of drop out due to the port system will be very small. The adverse events related to peritoneal access ports, such as catheter infections or obstructions, were observed in 6% of the cases in phase III trial for gastric cancer []. However, no patients dropped out because of the port system. There were no adverse events related to peritoneal access port in phase I trial for colorectal cancer []. Written informed consent will be obtained from all the patients. the University of Tokyo Ethics Committee approved this study (2021036-11DX). The study was registered Japan Registry of Clinical Trials (jRCT2031220110). Methods: This multicenter, open-label, single assignment interventional clinical study includes patients with colorectal cancer with unresectable peritoneal carcinomatosis. FOLFOX-bevacizumab or CAPOX-bevacizumab is administered concomitantly as systemic chemotherapy. PTX 20 mg/m2 is administered weekly through the peritoneal access port in addition to these conventional systemic chemotherapies. The response rate is the primary endpoint. Progression-free survival, overall survival, peritoneal cancer index improvement rate, rate of negative peritoneal lavage cytology, safety, and response rate to peritoneal metastases are the secondary endpoints. A total of 38 patients are included in the study. In the interim analysis, the study will continue to the second stage if at least 4 of the first 14 patients respond to the study treatment. The study has been registered at the Japan Registry of Clinical Trials (jRCT2031220110)."