Observational Study Protocol: LIVER-R

What this study is about

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).

Who can join (things the study team will check)

✅ You may be able to join if…

• Age ≥18 years and a lawful adult in the country at the index date
• Confirmed presence of malignancy of primary hepatobiliary cancer by any method (e.g., radiological, histological, etc.)
• Decision to treat was made independently and prior to obtaining informed consent
• Informed consent was obtained as per country level regulations (includes waiver of consent for retrospective data collection if approved) aBTC Specific Inclusion Criteria A patient will be eligible to be included in the aBTC cohort if they meet all general inclusion criteria 1-4 in addition to the following criteria:
• Patient has unresectable aBTC
• Has received or is intending to receive a durvalumab-based regimen (may have been treated in an EAP) uHCC Specific Inclusion Criteria A patient will be eligible to be included in the uHCC cohort if they meet all general inclusion criteria 1-4 in addition to the following criteria:
• Patient has unresectable uHCC
• Not eligible for LRT, as well as for those who progressed following LRT
• Has received or is intending to receive a durvalumab-based regimen (may have been treated in an EAP) eeHCC Specific Inclusion Criteria A patient will be eligible to be included in the eeHCC cohort if they meet all general inclusion criteria 1-4 in addition to the following criteria:
• HCC confirmed by radiological or histological diagnosis
• Child-Pugh A-B7
• Disease not amenable to curative treatment but amenable to LRT at index
• Patients with liver-confined HCC who initiated first non-curative intent LRT on or after 01 January 2024
• Patients eligible for LRT with palliative intent such as TACE/ TARE/transarterial infusion chemotherapy (TAIC)/ hepatic arterial infusion chemotherapy (HAIC)/transarterial embolization (TAE) given by itself or in combination with other systemic therapy (can include durvalumab) within 60 days of the LRT EMERALD Specific Inclusion Criteria A patient will be eligible to be included in the EMERALD cohort if they meet all general inclusion criteria 1-4 in addition to the following criteria:
• HCC confirmed by radiological or histological diagnosis
• Child-Pugh score of A-B7
• Liver-confined disease not amenable to curative treatment but amenable to LRT at index
• Receipt of a durvalumab-based regimen in combination with LRT administered within 28 days of each other (index is the first of the two treatments administered)

🚫 You may not be able to join if…

• Currently/was participating or plans to participate in any clinical trial for investigational treatment for hepatobiliary cancers on or after the diagnosis date until the index date
• Second primary malignancy prior to HCC or BTC diagnosis aBTC Specific Exclusion Criteria A patient will be excluded from participating in the aBTC cohort if they meet any of the general exclusion criteria 1-2 or any of the following criteria:
• Received a liver transplant during the baseline period
• Received more than 1 cycle of Gemcitabine + Cisplatin for biliary tract cancer on or after diagnosis of unresectable, locally advanced or metastatic disease through the index date. Patients who received any systemic therapy while having early stage, resectable disease are eligible uHCC Specific Exclusion Criteria A patient will be excluded from participating in the uHCC cohort if they meet any of the general exclusion criteria 1-2 or any of the following criteria:
• Received a liver transplant during the baseline period
• Received other systemic therapies for hepatobiliary cancer indication on or after diagnosis date through the index date eeHCC Specific Exclusion Criteria A patient will be excluded from participating in the eeHCC cohort if they meet any of the general exclusion criteria 1-2 or any of the following criteria:
• Eligible for curative therapy at the time of receiving LRT (ablation)
• Extrahepatic spread
• Portal vein tumor thrombosis (PVTT) of VP3/4
• Receipt of systemic therapy prior to index LRT in the baseline period
• Liver transplant any time prior to index EMERALD Specific Exclusion Criteria A patient will be excluded from participating in the EMERALD cohort if they meet any of the general exclusion criteria 1-2 or any of the following criteria:
• Eligible for curative therapy at the time of receiving LRT (ablation)
• Extrahepatic spread
• Portal vein tumor thrombosis (PVTT) of VP3/4
• Receipt of systemic therapy prior to index LRT in the baseline period
• Liver transplant any time prior to index

Where this trial is running

• Research Site, Birmingham, Alabama, United States
• Research Site, Mobile, Alabama, United States
• Research Site, Phoenix, Arizona, United States
• Research Site, Coronado, California, United States
• Research Site, Los Angeles, California, United States
• Research Site, Walnut Creek, California, United States
• Research Site, Clermont, Florida, United States
• Research Site, Gainesville, Florida, United States
• Research Site, Tampa, Florida, United States
• Research Site, Augusta, Georgia, United States
• Research Site, Evergreen Park, Illinois, United States
• Research Site, Hinsdale, Illinois, United States

+ 147 more sites.

Who to contact

AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06252753.