Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer.
Trial Parameters
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Brief Summary
The aim of this study is to evaluate the activity of first-line trastuzumab-deruxtecan, capecitabine and bevacizumab in terms of overall response rate for patients with HER-2 positive metastatic/locally advanced unresectable colorectal cancer
Eligibility Criteria
Inclusion Criteria: * Written informed consent obtained from the patient/legal representative before performing any protocol-related procedures, including screening evaluations. * Patient state to comply with all the study procedures and treatments. Patients must be accessible for treatment and follow-up. Patients registered for this trial must be treated and followed at the participating Centre. * Age ≥ 18 years at the time of informed consent. * ECOG Performance Status ≤ 2. * Life expectancy of ≥ 3 months. * Have histologically documented adenocarcinoma of the colon or rectum, which is initially metastatic or unresectable locally advanced. * Subjects must be willing to provide the most recently available formalin-fixed paraffin-embedded tumor tissue blocks (or at least 25 freshly sectioned slides) for translational analyses (sampled before 1st treatment course). If archival tissue is not available for HER2 testing or for exploratory aims, then a newly obtained baseline biopsy of an a