An observational study in HepatoCellular Carcinoma, sponsored by AstraZeneca. Recruiting at 17 sites in 7 countries. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by AstraZeneca · Observational
Hepatocellular carcinoma (HCC) is the sixth most commonly diagnosed cancer and the third reason for cancer-related death worldwide. Cirrhosis is a common risk factor of HCC, as it is found in approximately 70-90% of patients with HCC. Hepatitis C (HCV) and alcohol consumption represent the main causes of cirrhosis and HCC in Western countries; however, hepatitis B virus (HBV) is the leading cause of HCC and cirrhosis in East Asia and Africa. Moreover, HBV and HCV are considered the most common causes of HCC in about 80%-90% of patients. In addition, steatotic liver disease (SLD) is considered one of the main causes of HCC and cirrhosis. Unfortunately, the burden of HCC is great in Middle Eastern and North African (MENA) countries because of the high prevalence of HCV and HBV and the increasing incidence of SLD and metabolic-associated steatohepatitis (MASH).
Several studies illustrated that there are great disparities in the survival rate of patients with HCC according to patient characteristics such as gender, age, and socioeconomic status. In addition, the etiology of HCC may impact the survival and the response to treatment. Moreover, the incidence of HCC could be decreased by the prevention and/or appropriate management of HCC risk factors, especially HBV, HCV infections, and SLD. Therefore, understanding the etiology, patient characteristics, pathogenesis, and optimal management of HCC in the region is considered of prime importance to improve the patient journey of HCC in the MENA region.
The Middle East encompasses countries with varying levels of healthcare development and resources. There is a significant disparity in access to diagnostic tools, therapeutic options, and liver transplantation services. While some countries possess advanced healthcare systems with state-of-the-art facilities, others face challenges such as limited healthcare infrastructure, shortage of specialized healthcare professionals, and inadequate screening programs. These disparities significantly affect the early detection, management, and outcomes of HCC patients.
This study aims to assess the etiology, clinical and tumor characteristics, and treatments received for HCC, as well as clinical outcomes (OS, PFS) in different countries in the MENA region.
3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 200 across 850 observational studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
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Data from patients' medical charts will be gathered from 3 to 5 tertiary referral centers per country across 10 countries in the MENA region, including Egypt, KSA, the United Emirates, Lebanon, Kuwait, Qatar, Iraq, Morocco, Jordan, and Turkey. The study population comprises patients diagnosed with HCC between January 1, 2015, and December 31, 2023, across these participating centers.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient Clinical Characteristics
Type of HCC at diagnosis
Time frame: 8 Years
Patient demographics
Disease duration in years
Time frame: 8 Years
Tumor characteristics
Severity of liver disease on presentation as assessed by the Child-Turcotte-Pugh (CTP) score and classes
Time frame: 8 Years
To describe the risk factors (etiology) of HCC
Proportion of patients with each risk factor: * Viral hepatitis (B, C, and D). * ALD * SLD
Time frame: 8 Years
To describe the treatment patterns in patients with HCC
The percentage of patients receiving each of the following treatment regimens alone or in combination, along with the duration, and treatment discontinuation frequency and reasons in different countries: * Tumor resection * Liver transplantation * Local ablation (ethanol, radiofrequency, microwave) * TACE (conventional, drug-eluting beads (DEB) * TARE (Yttrium-9- Microspheres, Lipiodol labelled with iodine131 or rhenium188) * Tyrosine kinase inhibitors (Sorafenib, Lenvatinib, Regorafenib, Cabozantinib) * Immune checkpoint inhibitors (Nivolumab, Pembrolizumab, Atezolizumab, Tislelizumab, Durvalumab, Tremelimumab)
Time frame: 8 Years
To describe the overall survival rate (OS)
Patient survival stratified by participating countries: o OS
Time frame: 8 Years
To Describe Progression Free Survival
The date of each progression from stage to another stage.
Time frame: 8 Years
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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