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.
Single group
Trastuzumab-Deruxtecan (T-DXd)
DrugT-DXd at the dose of 5.4 mg/kg intravenous (as a 90 +/- 10 minute infusion) on day 1 every 3 weeks
Capecitabine
Drug1000 mg/sqm bis in die (BID) orally on days 1-14 every 3 weeks
Bevacizumab
Drug7.5 mg/kg intravenous (as a 30 minute infusion) on day 1 every 3 weeks
Overall Response Rate
Overall response rate will be defined as the proportion of patients who achieve either a partial or complete response as best responses to study treatment according to RECIST v1.1 criteria. Response will be assessed as per blinded independent central review
Progression-free survival
Progression-free survival is defined as the time from treatment start to radiological evidence of disease progression (as per RECIST v1.1 criteria) or death, whichever occurs first. PFS will be assessed by BICR and Investigator-assessed.
Overall survival
Overall survival is defined as the time from treatment start to death.
Treatment safety
Treatment safety is defined as the incidence of adverse events during treatment and follow-up, assessed according to CTCAE v5.0.
Disease control rate
Disease control rate (DCR) by BICR and Investigator assessment, defined as the proportion of subjects achieving a complete response (CR), partial response (PR) or stable disease (SD) as best response during study treatment, as per RECIST v1.1.
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Gruppo Oncologico del Nord-Ovest
Lead sponsor
AstraZeneca
Collaborator
