Safety and feasibility evaluation of short-time administration (30-minute dose) of panitumumab in combination therapy with FOLFOX for unresectable advanced or recurrent colorectal cancer: single-arm trial

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适应症

试验速览

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•Patients who have been histologically or cytologically diagnosed with colorectal cancer.
•Patients with unresectable advanced or recurrent disease for whom systemic chemotherapy is indicated.
•Patients confirmed to have wild-type RAS genes, including KRAS and NRAS.
•Patients scheduled to newly initiate the PANI plus FOLFOX combination regimen.
•Patients aged 20 years or older.
•Patients with an ECOG Performance Status (PS) of 0 or
•Patients with adequate organ function who are judged by the attending physician to be able to tolerate systemic treatment.
•Patients who have provided written informed consent to participate in this study.

•Patients with a history of prior treatment with PANI or other anti-EGFR antibody agents.
•Patients with hypersensitivity to PANI or any of its excipients.
•Patients with a history of Grade 2 or higher infusion reaction (IR).
•Patients with active pulmonary tuberculosis, poorly controlled HBV infection, or other active infections requiring treatment.
•Patients with comorbidities, such as severe cardiovascular or respiratory disease, that are judged to make participation in the study difficult.
•Patients confirmed to have MSI-High or dMMR disease.
•Patients confirmed to have a BRAF V600E mutation.
•Women who are pregnant, breastfeeding, or may be pregnant.
•Body weight is 166 kg or more.
•Patients who are judged by the principal investigator or a sub-investigator to be unsuitable for participation in the study for any other reason.

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