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
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.
Have previously received any systemic anticancer therapy for CRC in the metastatic/locally advanced unresectable setting or have participated in any interventional clinical trial for CRC in the metastatic/locally advanced unresectable setting. Subjects may have received prior fluoropyrimidine with or without oxaliplatin for CRC in the adjuvant or neoadjuvant setting if it was completed > 6 months before enrollment.
Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive brain metastases may be included in the study. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.
Have previously been treated with an anti-HER2 agent and/or a topoisomerase I inhibitor.
Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medications.
Gruppo Oncologico del Nord-Ovest
Lead sponsor
AstraZeneca
Collaborator