HepatoCellular CarcinomaNCT07650773
CHARM Hepatocellular Carcinoma MEA Study
An observational study of HepatoCellular Carcinoma, run by AstraZeneca at 17 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HepatoCellular Carcinoma
- How many people
- 4,000 participants
- Where
- 17 sitesin 7 countries
- Study dates
- 14 Jul 2026to 30 Nov 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
17 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
17 sites in 7 countries
Egypt4 sites, 4 recruiting
- Not yet recruiting
Research Site
Al Mansurah
- Not yet recruiting
Research Site
Dakahlia
- Not yet recruiting
Research Site
Damietta
- Not yet recruiting
Research Site
Menouf
Saudi Arabia4 sites, 4 recruiting
- Not yet recruiting
Research Site
Dammam
- Not yet recruiting
Research Site
Jeddah
- Not yet recruiting
Research Site
Mecca
- Not yet recruiting
Research Site
Riyadh
Turkey (Türkiye)4 sites, 4 recruiting
- Not yet recruiting
Research Site
Ankara
- Not yet recruiting
Research Site
Erzurum
- Not yet recruiting
Research Site
Istanbul
- Not yet recruiting
Research Site
Izmir
United Arab Emirates2 sites, 2 recruiting
- Not yet recruiting
Research Site
Abu Dhabi
- Recruiting
Research Site
Al Ain City
About this study
Official 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
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.
Read more
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.
- Conditions
- HepatoCellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Clinical Characteristics
Type of HCC at diagnosis
Measured: 8 Years
Patient demographics
Disease duration in years
Measured: 8 Years
Tumor characteristics
Severity of liver disease on presentation as assessed by the Child-Turcotte-Pugh (CTP) score and classes
Measured: 8 Years
Secondary outcomes (4)
To describe the risk factors (etiology) of HCC
Proportion of patients with each risk factor:
- Viral hepatitis (B, C, and D).
- ALD
- SLD
Measured: 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)
Measured: 8 Years
To describe the overall survival rate (OS)
Patient survival stratified by participating countries:
- OS
Measured: 8 Years
To Describe Progression Free Survival
The date of each progression from stage to another stage.
Measured: 8 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start14 Jul 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatoCellular CarcinomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650773
- Sponsor's protocol ID
- D419CR00057
- Status last verified
- Oct 2026
- First submitted
- 11 Jun 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.