Observational Study to Track Real-World Outcomes of Durvalumab-Based Treatments in Hepatobiliary Cancers

What this Trial Is About

Researchers are conducting a large real-world observational study called LIVER-R to gather data on patients with hepatobiliary cancers, specifically unresectable hepatocellular carcinoma uHCC and advanced biliary tract cancers aBTC. The study aims to evaluate the outcomes of patients treated with durvalumab-based regimens, including combinations like STRIDE and durvalumab plus chemotherapy, as part of routine clinical practice or early access programs. This study is descriptive and noncomparative, focusing on real-world effectiveness and clinical characteristics across multiple countries and centers. The study will collect both primary data during patients routine visits and secondary data from medical records at enrollment and every 6 months. It includes a baseline period of up to 5 years before starting durvalumab treatment and a follow-up period lasting up to 3 years for uHCC patients and 2 years for aBTC patients. Data collected will cover treatment patterns, clinically significant events, concomitant medications, and various real-world clinical outcomes such as survival rates, progression-free survival, time to treatment progression, and recurrence-free survival. Participants will be adults diagnosed with hepatobiliary cancer and treated with durvalumab-based regimens as decided by their physicians. Researchers will monitor overall survival and other outcomes at multiple time points over the follow-up period. Data collection involves routine clinical visits, medical record review, and tracking of treatment and event timelines. The study will provide insights into the real-world use and outcomes of durvalumab therapies for these cancers, with continuous monitoring until death, withdrawal, loss to follow-up, or study completion.

Observational Study Protocol: LIVER-R