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NCT Number: NCT07650773

CHARM Hepatocellular Carcinoma MEA Study

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a radiological or histopathological confirmed diagnosis with HCC in any stage of the tumor between 1st January 2015 and 31st December 2023 (defined as index date).
  • Patient or next of kin/legal representative (for deceased patients at study entry, unless a waiver is granted) willing and able to provide written informed consent according to the local regulations
  • Age 18 years or older, and a lawful adult in the country at the index date
  • Patients with medical records, including etiology, laboratories, radiological, and treatment details will be collected from the participating sites.
  • Patients with medical records covering at least a 6-month follow-up period, defined as the time from the index date (the date of the first diagnosis) to the earliest of the following: the patient's death, the last medical record entry, or the data extraction date. Additionally, patients who died within this 6-month period will also be included.

Exclusion criteria

  • Patients with other cancer diagnosis on or before index date.
  • Patients with records missing information on etiology, laboratory results, radiological findings, or treatment details (≥30% of key variables).
  • Previously opted out of sharing medical records
  • Patients participating in clinical trials
  • Pregnant patient

Treatment and study plan

Primary outcomes

  1. Patient Clinical Characteristics

    Time frame: 8 Years

    Type of HCC at diagnosis

  2. Patient demographics

    Time frame: 8 Years

    Disease duration in years

  3. Tumor characteristics

    Time frame: 8 Years

    Severity of liver disease on presentation as assessed by the Child-Turcotte-Pugh (CTP) score and classes

Secondary outcomes

  1. To describe the risk factors (etiology) of HCC

    Time frame: 8 Years

    Proportion of patients with each risk factor:

    • Viral hepatitis (B, C, and D).
    • ALD
    • SLD
  2. To describe the treatment patterns in patients with HCC

    Time frame: 8 Years

    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)
  3. To describe the overall survival rate (OS)

    Time frame: 8 Years

    Patient survival stratified by participating countries:

    o OS

  4. To Describe Progression Free Survival

    Time frame: 8 Years

    The date of each progression from stage to another stage.

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Multicountry, Multicenter, Secondary Data Collection, Retrospective Observational Study to Describe the Characteristics and Management of Hepatocellular Carcinoma (HCC) Among Adults in the Middle East Region

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 16, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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