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Taking people in Saudi ArabiaNo phase

Follows people with liver and bile duct cancers treated with or without durvalumab

Observes real-world outcomes of durvalumab-based and other treatments in adults with hepatobiliary cancer.

Key facts

Who runs it
AstraZeneca
Where
Jeddah and Riyadh, Saudi ArabiaSee the 2 sitesAlso in 21 other countries, 144 sites
Trial code
Registry title
Observational Study Protocol: LIVER-R
Status
Recruiting
People taking part
4,000 people, planned
Started
20 Dec 2023
Expected to end
30 Dec 2030
Type of study
Observational, 4 groups
Treatments tested
  • Durvalumab-based combination therapies in observational study setting
  • Non Durvalumab-based therapies in observational study setting
  • Durvalumab-based combination therapies in observational study settings
Record updated
28 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with liver or bile duct cancer that cannot be removed by surgery. It follows real-world treatment, with or without durvalumab-based regimens.

Age
18 years and older
Sex
All sexes can join.
Disease stage
Hepatobiliary cancer that cannot be removed by surgery: advanced biliary tract cancer, or liver cancer (HCC). Some groups need liver-confined disease treated with local liver treatment (LRT) and Child-Pugh A-B7.
Earlier treatment
Some groups need a durvalumab-based regimen, already received or planned. Some groups cannot have had other systemic therapy for the cancer, or any systemic therapy before the local liver treatment.

Main reasons for not taking part

  • Taking part in a trial of an experimental treatment for hepatobiliary cancer
  • A second primary cancer before the liver or bile duct cancer diagnosis
  • Liver transplant
  • Cancer spread outside the liver (in the local liver treatment groups)
  • Cancer that can still be treated with the aim of removing it completely (in the local liver treatment groups)

The registry criteria, word for word

Show all 37 criteriaShow less

Who can take part

  • All patients must meet all of the following general criteria 1-4 along with all respective cohort specific criteria noted below:
  • 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)

Who cannot take part

  • 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)
  • 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)
  • Receipt of systemic therapy prior to index LRT in the baseline period
  • Liver transplant any time prior to index
  • 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
  • Portal vein tumor thrombosis (PVTT) of VP3/4
  • Portal vein tumor thrombosis (PVTT) of VP3/4
  • General Exclusion Criteria
  • A patient will be excluded from participating in this study if they meet any of the following general criteria 1-2 or any cohort specific exclusion criteria:
  • Extrahepatic spread
  • Extrahepatic spread

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 130 years old?

Where in Saudi Arabia

Also in 21 other countries, 144 sites

  • JeddahHospital not named in the registryTaking people
  • RiyadhHospital not named in the registryTaking people

About the trial

What the trial wants to find out

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 ).

The 4 groups in the trial

  • unresectable hepatocellular carcinoma (uHCC)

    advanced uHCC patients who had not received prior systemic therapy and were not eligible for LRT, as well as those who had progressed following LRT, and who have received a durvalumab-based regimen

    Treatment: Durvalumab-based combination therapies in observational study setting

  • advanced biliary tract cancer (aBTC)

    patients with advanced BTC (aBTC) who are not eligible for resection and who have received a durvalumab-based regimen

    Treatment: Durvalumab-based combination therapies in observational study setting

  • eeHCC

    uHCC patients with liver-confined disease not amenable to curative treatment but amenable to LRT who receive LRT alone or LRT followed by systemic therapy within 60 days (if administered in combination, LRT must be received first)

    Treatment: Non Durvalumab-based therapies in observational study setting

  • EMERALD

    uHCC patients with liver-confined disease not amenable to curative treatment but amenable to LRT who receive durvalumab-based regimens in combination with LRT (durvalumab and LRT are given within 28 days of each other, regardless of order)

    Treatment: Durvalumab-based combination therapies in observational study settings

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
An Observational Multi-Center Study to Evaluate Real-World Treatment Outcomes With or Without Durvalumab-Based Regimens in Hepatobiliary Cancers
Plain-language title
Follows people with liver and bile duct cancers treated with or without durvalumabGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06252753, who can take part
Publications
Record updated
28 October 2026