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Observational study on durvalumab treatment for liver cancers

An Observational Multi Center Study to Evaluate Real World Treatment Outcomes of Durvalumab Based Regimens in Hepatobiliary Cancers

Observational AstraZeneca · NCT06252753

This study is trying to see how well a treatment called durvalumab works for people with advanced liver cancers that can’t be surgically removed.

Quick facts

Study typeObservational
Enrollment4490 (estimated)
Ages18 Years to 130 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsdurvalumab
Locations138 sites (Birmingham, Alabama and 137 other locations)
Trial IDNCT06252753 on ClinicalTrials.gov

What this trial studies

LIVER-R is a multicountry, multicenter observational study designed to gather real-world data on patients with unresectable hepatocellular carcinoma (uHCC) and advanced biliary tract cancers (aBTC) treated with durvalumab-based regimens. The study aims to enroll approximately 2500 patients across 22 countries, collecting both primary data during routine clinical visits and secondary data from medical records. The primary objective is to evaluate the effectiveness of these treatments in terms of overall survival, while also assessing treatment patterns and other clinical outcomes over a follow-up period of up to three years.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of unresectable hepatocellular carcinoma or advanced biliary tract cancer who are being treated with a durvalumab-based regimen.

Not a fit: Patients currently participating in clinical trials for investigational treatments for hepatobiliary cancers may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of durvalumab-based therapies in real-world settings for patients with hepatobiliary cancers.

How similar studies have performed: Other studies have shown success with similar observational approaches in capturing real-world data for cancer treatments, making this a promising avenue for further exploration.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age ≥18 years and a lawful adult in the country at the index date
2. Confirmed presence of malignancy of primary hepatobiliary cancer (i.e., uHCC or aBTC) by the treating physician
3. Type of hepatobiliary cancer indication is approved to be treated (i.e., positive phase 3 clinical trial read out for HIMALAYA or TOPAZ 1) with a durvalumab based regimen in the respective country or was administered as part of an EAP
4. Informed consent was obtained as per country level regulations on or after the index date

Exclusion Criteria:

1. 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
2. Received other systemic therapies for hepatobiliary cancer indication on or after diagnosis date through the index date (e.g., uHCC or aBTC patient who received a systemic treatment for unresectable HCC or advanced BTC, respectively, prior to initiating durvalumab based regimen)
3. Received a liver transplant during the baseline period

Where this trial is running

Birmingham, Alabama and 137 other locations

+88 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hepatobiliary CancersHepatobiliary cancerUnresectable hepatocellular carcinomaAdvanced biliary tract cancerDurvalumabObservatoryReal-world
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.