LIVER-R study protocol: a global real-world study of durvalumab-based regimens in patients with hepatobiliary cancers.

[BACKGROUND] Durvalumab-based regimens have improved outcomes compared with standard of care in unresectable hepatocellular carcinoma (uHCC) and advanced biliary tract cancer (aBTC) clinical trials. Here we describe the protocol for the LIVER-R study, which will evaluate long-term outcomes with durvalumab-based regimens in patients with hepatobiliary cancers in real-world settings.

[METHODS] LIVER-R (NCT06252753) is an observational study aiming to initially enroll ~2500 adults with uHCC or aBTC from ~179 sites in 22 countries. Patients treated with durvalumab-based regimens as part of routine clinical practice or a global early access program will be included. The primary outcome is overall survival. Secondary outcomes include duration of treatment, progression-free survival, treatment patterns and safety. Data will be collected at baseline and every 6 months. The study will include a baseline period of up to 5 years before index date (initiation of first-line durvalumab-based regimen) and a follow-up period from index until death, loss to follow-up, withdrawal, or study end. Study variables will be analyzed descriptively; time-to-event outcomes will be analyzed using the Kaplan-Meier method.

[CONCLUSIONS] LIVER-R will produce a large, global, real-world standardized dataset of patients with uHCC or aBTC treated with a durvalumab-based regimen, providing insights into real-world clinical practice.

[CLINICAL TRIAL REGISTRATION] www.clinicaltrials.gov identifier is NCT06252753.