EFFIPEC – Efficacy of Hyperthermic Intraperitoneal ChemotherapySingle-arm Phase I study, followed by an open-label, randomized, controlled registry-based phase III trial - EFFIPEC01

ppsala University0 个研究点目标入组 230 人开始时间: 2024年8月8日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•Provision of written informed consent prior to any study specific procedures., ECOG Performance Status Score 0,1 or 2, alternatively Karnofsky 60-100., Adequate kidney, liver, bone marrow function according to laboratory tests., For females of childbearing potential, a negative pregnancy test must be documented., = 18 years old and <=78 years old., Colorectal cancer with peritoneal metastases +/- liver metastases., Concomitant resectable pulmonary metastases., All patients deemed eligible for CRS and HIPEC according to clinical routine.

•Previous severe toxicity/allergic reactions to systemic chemotherapy agents oxaliplatin or irinotecan or 5-fluorouracil, Histopathology of other origin than colorectal cancer., Unable to tolerate intensified HIPEC treatment due to comorbidity., Metastasis other than peritoneum or liver or lung (ie paraaortal lymph node or bone metastases), Previous CRS or HIPEC., Pregnant or lactating (nursing) women., Active infections requiring antibiotics., Active liver disease with positive serology for active hepatitis B, C, or known HIV, Concurrent administration of any cancer therapy other than planned study treatment within 4 weeks prior to and up to 4 weeks after study treatment., Incomplete cytoreduction defined as completeness of cytoreduction score 2-3.

发起方

ppsala University