BCLC Stage B Hepatocellular CarcinomaNCT07449637
Real-World Treatment Patterns and Survival Outcomes in Patients With Intermediate-Stage Hepatocellular Carcinoma.
An observational study of BCLC Stage B Hepatocellular Carcinoma, run by Sohag University at 1 site in Egypt.
Trial summary
The goal of this observational study is to learn about the different treatment options for intermediate-stage hepatocellular carcinoma. The main question it aims to answer is: What are the survival outcomes among participants aged 18 or older who receive treatment for intermediate-stage hepatocellular carcinoma? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BCLC Stage B Hepatocellular Carcinoma
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2026to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with intermediate-stage hepatocellular carcinoma (BCLC-B) treated at Sohag Oncology Center.
Who may be able to join
- Aged ≥18 years.
- Both sexes.
- Diagnosis of hepatocellular carcinoma based on accepted radiologic or histologic criteria.
- Classified as intermediate stage (BCLC-B) at time of decision for first-line treatment.
- Child-Pugh A or B.
- ECOG performance status 0-1.
Who cannot join
- BCLC A, C, or D at diagnosis.
- Prior curative therapy (resection, transplantation, curative ablation).
- Missing essential data (imaging, liver function, treatment records).
- Mixed HCC-cholangiocarcinoma.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag Oncology Center
Sohag, Sohag Governorate
Mohammed Hamdy, +201101501551, mohammedzohry2018@gmail.com
About this study
Official title: Real-World Treatment Patterns and Survival Outcomes in Patients With Intermediate-Stage Hepatocellular Carcinoma: An Observational Cohort Study.
The goal of this observational study is to learn about the different treatment options for intermediate-stage hepatocellular carcinoma. The main question it aims to answer is:
- What are the survival outcomes among participants aged 18 or older who receive treatment for intermediate-stage hepatocellular carcinoma?
Read the detailed description
Aim of work:
- To evaluate real-world treatment patterns and survival outcomes among patients with intermediate-stage hepatocellular carcinoma (BCLC-B) treated at a tertiary care center.
Study Design:
- Observational cohort study.
Study Setting:
- Single-center study at Sohag Oncology Center.
Study Period:
- 01 January 2020 - 31 December 2025.
Sample Size:
- Expected cohort: 120-300 patients.
- Adequate for survival analysis and multivariable modeling in real-world studies.
Data Collection
- Baseline Characteristics:
- Age, sex
- Etiology of liver disease (HBV, HCV, MASH, …)
- AFP level
- Child-Pugh score
- ALBI grade
- Tumor burden (number, size of largest lesion, bilobar involvement)
- Treatment Variables
- Type of initial therapy
- Number of TACE sessions
- Time to TACE refractoriness
- Use of systemic therapy (Tyrosine Kinase inhibitors, Immunotherapy, combinations)
- Treatment sequencing
Statistical analysis:
- Statistical analysis will be performed by SPSS 24.0 software (SPSS, Inc., Chicago, IL).
- Descriptive statistics for baseline characteristics.
- Kaplan-Meier survival curves for OS and PFS.
- Log-rank test for group comparisons.
- Multivariable Cox proportional hazards regression to identify predictors of survival.
- Subgroup analyses:
- Up-to-7 in vs out.
- Child-Pugh A vs B.
- TACE-only vs sequential/systemic.
Study Objectives:
- Primary Objective
- To estimate overall survival (OS) among patients with intermediate-stage HCC receiving real-world treatment.
- Secondary Objectives
- To describe real-world treatment patterns (First-line, subsequent lines, combination therapies) and time to treatment changes.
- To estimate progression-free survival (PFS) and time to treatment failure (TTF) by treatment group.
- To evaluate safety signals (hospitalizations for treatment-related complications) in each treatment group.
- To identify predictors of survival, including:
- Tumor burden.
- Child-Pugh class.
- Laboratory markers (AFP, Bilirubin, Albumin).
- Conditions
- BCLC Stage B Hepatocellular Carcinoma
- Keywords
- Intermediate-Stage Hepatocellular Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with intermediate-stage hepatocellular carcinoma (BCLC-B) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall survival (OS) is defined as the time from randomization to death.
Measured: From randomization to the end of treatment at 5 years.
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the time from randomization until first evidence of disease progression or death.
Measured: From randomization to the end of treatment at 5 years.
Objective response (mRECIST)
According to mRECIST for HCC, CR is the disappearance of any intratumoral arterial enhancement in all target lesions. PR is at least a 30% decrease in the sum of the diameters of viable (contrast enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of the target lesions. Overall response is a result of the combined assessment of target lesions, nontarget lesions and new lesions.
Measured: From randomization to the end of treatment at 5 years.
Adverse events (CTCAE)
An Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. This definition is standardized by the Common Terminology Criteria for Adverse Events (CTCAE) system to ensure consistent reporting and grading of toxicity severity across studies.
Measured: From randomization to the end of treatment at 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BCLC Stage B Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Collaborators
- Sohag Oncology Center
- Responsible party
- Principal investigator, Mohammed Hamdy Zohry, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449637
- Sponsor's protocol ID
- Soh-Med-26-1-9MS
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Treatment Patterns and Survival Outcomes in Patients With Intermediate-Stage Hepatocellular Carcinoma: An Observational Cohort Study.
- ClinicalTrials.gov ID
- NCT07449637
- Acronym / sponsor ID
- Soh-Med-26-1-9MS
- Conditions
- BCLC Stage B Hepatocellular Carcinoma
- Keywords
- Intermediate-Stage Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Collaborators
- Sohag Oncology Center
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about the different treatment options for intermediate-stage hepatocellular carcinoma. The main question it aims to answer is:
- What are the survival outcomes among participants aged 18 or older who receive treatment for intermediate-stage hepatocellular carcinoma?
Detailed description
Aim of work:
- To evaluate real-world treatment patterns and survival outcomes among patients with intermediate-stage hepatocellular carcinoma (BCLC-B) treated at a tertiary care center.
Study Design:
- Observational cohort study.
Study Setting:
- Single-center study at Sohag Oncology Center.
Study Period:
- 01 January 2020 - 31 December 2025.
Sample Size:
- Expected cohort: 120-300 patients.
- Adequate for survival analysis and multivariable modeling in real-world studies.
Data Collection
- Baseline Characteristics:
- Age, sex
- Etiology of liver disease (HBV, HCV, MASH, …)
- AFP level
- Child-Pugh score
- ALBI grade
- Tumor burden (number, size of largest lesion, bilobar involvement)
- Treatment Variables
- Type of initial therapy
- Number of TACE sessions
- Time to TACE refractoriness
- Use of systemic therapy (Tyrosine Kinase inhibitors, Immunotherapy, combinations)
- Treatment sequencing
Statistical analysis:
- Statistical analysis will be performed by SPSS 24.0 software (SPSS, Inc., Chicago, IL).
- Descriptive statistics for baseline characteristics.
- Kaplan-Meier survival curves for OS and PFS.
- Log-rank test for group comparisons.
- Multivariable Cox proportional hazards regression to identify predictors of survival.
- Subgroup analyses:
- Up-to-7 in vs out.
- Child-Pugh A vs B.
- TACE-only vs sequential/systemic.
Study Objectives:
- Primary Objective
- To estimate overall survival (OS) among patients with intermediate-stage HCC receiving real-world treatment.
- Secondary Objectives
- To describe real-world treatment patterns (First-line, subsequent lines, combination therapies) and time to treatment changes.
- To estimate progression-free survival (PFS) and time to treatment failure (TTF) by treatment group.
- To evaluate safety signals (hospitalizations for treatment-related complications) in each treatment group.
- To identify predictors of survival, including:
- Tumor burden.
- Child-Pugh class.
- Laboratory markers (AFP, Bilirubin, Albumin).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with intermediate-stage hepatocellular carcinoma (BCLC-B) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with intermediate-stage hepatocellular carcinoma (BCLC-B) treated at Sohag Oncology Center.
Key inclusion criteria (6 listed)
- Aged ≥18 years.
- Both sexes.
- Diagnosis of hepatocellular carcinoma based on accepted radiologic or histologic criteria.
- Classified as intermediate stage (BCLC-B) at time of decision for first-line treatment.
- Child-Pugh A or B.
Key exclusion criteria (4 listed)
- BCLC A, C, or D at diagnosis.
- Prior curative therapy (resection, transplantation, curative ablation).
- Missing essential data (imaging, liver function, treatment records).
- Mixed HCC-cholangiocarcinoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival (OS)
Time frame: From randomization to the end of treatment at 5 years.
Overall survival (OS) is defined as the time from randomization to death.
Progression-Free Survival (PFS)
Time frame: From randomization to the end of treatment at 5 years.
Progression-free survival (PFS) is defined as the time from randomization until first evidence of disease progression or death.
Objective response (mRECIST)
Time frame: From randomization to the end of treatment at 5 years.
According to mRECIST for HCC, CR is the disappearance of any intratumoral arterial enhancement in all target lesions. PR is at least a 30% decrease in the sum of the diameters of viable (contrast enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of the target lesions. Overall response is a result of the combined assessment of target lesions, nontarget lesions and new lesions.
Adverse events (CTCAE)
Time frame: From randomization to the end of treatment at 5 years.
An Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. This definition is standardized by the Common Terminology Criteria for Adverse Events (CTCAE) system to ensure consistent reporting and grading of toxicity severity across studies.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BCLC Stage B Hepatocellular Carcinoma, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Hamdy (+201101501551, mohammedzohry2018@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: From randomization to the end of treatment at 5 years.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.