The CRISTAL-APC trial has reached a significant milestone, with all necessary regulatory approvals successfully granted on 25 February 2025. This achievement marked the formal start of the study’s next phase—site setup and initiation. Following the approvals, the trial team moved swiftly to prepare Addenbrooke’s Hospital in Cambridge as the first site to host the study.
In the weeks following approval, the CRISTAL-APC trial team worked closely with the Addenbrooke’s site team to prepare for the trial opening. This included comprehensive training for site staff on the trial protocol, informed consent procedures, data collection methods, and safety monitoring processes. The training ensured that all personnel involved in the study were fully equipped to conduct the trial in accordance with Good Clinical Practice (GCP) guidelines and regulatory requirements.
On 6 April 2025, Addenbrooke’s Hospital was officially opened to recruitment, becoming the first site in the UK to begin enrolling participants into the CRISTAL-APC trial. This marks a key step forward in the delivery of the study, which aims to evaluate a novel therapeutic approach for patients with advanced pancreatic cancer.
The successful setup and activation of the Addenbrooke’s site is a testament to the close collaboration between the trial sponsor, site staff, research nurses, and clinical teams. Recruitment will initially focus on patients who meet the study’s eligibility criteria, with 4 additional trial sites expected to open in the coming months.
