AstraZeneca
Given the number of anticipated durvalumab-based treatment launches in the hepatobiliary cancer space over the next 3 years, there is a need to capture contemporary real-world data across these indications. LIVER-R is a multi-country, multi-center, observational study of patients with a confirmed diagnosis of hepatobiliary cancer treated with or without a durvalumab-based regimen as part of routine clinical practice or early access program (EAP). The study design will include primary and secondary data collection. The primary objective of this study is to evaluate the effectiveness of regimens (durvalumab-based or otherwise) in real-world settings as measured by real-world overall survival. Other endpoints include demographics, clinical characteristics, clinically significant events of interest, treatment patterns, concomitant medications, treatment provider characteristics, and other real-world clinical endpoints (such as duration of treatment, progression-free survival, time to treatment progression, time to next treatment, time to treatment discontinuation, recurrence-free survival, and time to treatment recurrence ).
LIVER-R is a real-world, multi-country, multi-centre study aiming to enroll approximately 4,000 patients across hepatobiliary cohorts (approximately 1,385 patients for aBTC, approximately 1,165 patients for uHCC, approximately 1,000 patients for eeHCC, and approximately 400 patients for EMERALD) across multiple countries from North and South America, Europe, the Middle East and the Asia-Pacific region. The study design will include primary and secondary data collection. Primary data will be collected in real-time during the patient's routine visit. Secondary data will be collected from the pat…
Inclusion Criteria General Inclusion Criteria All patients must meet all of the following general criteria 1-4 along with all respective cohort specific criteria noted below: 1. Age ≥18 years and a lawful adult in the country at the index date 2. Confirmed presence of malignancy of primary hepatobiliary cancer by any method (e.g., radiological, histological, etc.) 3. Decision to treat was made independently and prior to obtaining informed consent 4. Informed consent was obtained as per country level regulations (includes waiver of consent for retrospective data collection if approved) aBTC…
Data on patients who initiated durvalumab-based regimens, including STRIDE (Single Tremelimumab Regular Interval Durvalumab), will be collected).
Data on patients who initiated durvalumab-based regimens, including durvalumab + chemotherapy combinations (e.g., Durvalumab + GemCis etc.) will be collected.
Data on patients who initiated non durvalumab-based regimens, including LRT alone or LRT followed by systemic therapies, will be collected.
Data on patients who initiated durvalumab-based regimens in combination with LRT, will be collected