Pre-operative Administration of Anti-EGFR Monoclonal Antibodies (cetuximab) for the Eradication of Circulating Tumor Cells in Patients Undergoing Curative Treatment of Colorectal Liver Metastases; a dose finding study - PremAb-DOSE trial

Vrije Universiteit Medisch Centrum0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•- 18 years or older
•- informed consent
•- Presence of colorectal cancer liver metastases and patient eligible for local treatment of colorectal liver metastases
•- open, laparoscopic or percutaneous treatment of liver metastases, including surgical resection radiofrequent ablation, microwave ablation, irreversible electroporation or combinations of these therapies with curative intent.
•- no primary tumor in situ
•- A population EGFR/EpCAM+ tumor cells (positive for epithelial markers EpCAM and EGFR) detected in the first blood sample with flow cytometry.
•- Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must agree to use adequate barrier birth control measures (e.g., cervical cap, condom, and diaphragm) during the course of the trial. Oral birth control methods alone will not be considered adequate on this study, because of the potential pharmacokinetic interaction between study drug and oral contraceptives. Concomitant use of oral and barrier contraceptives is advised. Contraception is necessary for at least 6 months after receiving study drug.

•- Chemotherapy (< 4 weeks prior to surgery)
•- Evidence of extrahepatic colorectal cancer metastases
•- Prior anti-EGFR mAb therapy
•- Other currently active malignancy
•- Performance status > ASA 3 (American Society for Anaesthesiologists)
•- Expected adverse reactions/allergies for study medication
•- Mental disorder/unable to give informed consent
•- Pregnancy or breast-feeding patients
•- Significant skin condition interfering with treatment
•- Concurrent anticancer chemotherapy, immunotherapy or investigational drug therapy during the study or within 4 weeks of the start of study drug.
•- Radiotherapy to the target lesions during study or within 4 weeks of the start of study drug.
•- Major surgery within 28 days before start of study drug.
•- Substance abuse, medical, psychological or social conditions that may interfere with the subject*s participation in the study or evaluation of the study results.
•- Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.
•- Blood transfusion during or directly after surgery

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