RadiomicsNCT05889949
Microvascular Invasion for Guiding Treatment of Barcelona Clinic Liver Cancer Stage B Hepatocellular Carcinoma
An observational study of Radiomics and Hepatocellular Carcinoma (HCC), run by Sun Yat-sen University at 1 site in China.
Trial summary
The goal of this observational study is to explore the role of prediction of microvascular invasion by radiomics based on pre-treatment magnetic resonance imaging for guiding treatment of Barcelona Clinic Liver Cancer stage B hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Radiomics, Hepatocellular Carcinoma (HCC), Transcatheter Arterial Chemoembolization (TACE)
- What is being tested?
- Sorafenib and Lenvatinib
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 31 May 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: BCLC stage B HCC patients
Who may be able to join
- Age 18-75 years;
- BCLC stage B HCC;
- Received no previous anti-cancer treatment;
- At least 1 measurable intrahepatic lesion based on the Response Evaluation Criteria in Solid Tumors criteria (RECIST) 1.1;
- Adequate hematological, liver, renal function:
- absolute neutrophil count ≥ 1.5×109/L;
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- platelet count ≥ 100×109/L;
- hemoglobin concentration ≥ 90 g/L;
- albumin ≥ 28 g/L;
- total bilirubin < 1.5 times the upper limit of normal;
- alanine aminotransferase and aspartate aminotransferase < 5 times the upper limit of normal;
- blood urea nitrogen and serum creatinine concentration < 1.5 times the upper limit of the normal range or less and creatinine clearance rate ≥ 45 mL/min;
- Life expectancy of at least 3 months.
Who cannot join
- Acute or chronic active hepatitis B (HBV) or C (HCV) infection with HBV-DNA > 2000 IU/ml or 104 copies/ml; hepatitis C virus RNA > 103 copies/ml; HBsAg and anti-HCV antibody positive at the same time. Those who are below the above criteria after nucleoside based antiviral therapy may be enrolled;
- Life-threatening bleeding event within the past 3 months, including the need for blood transfusion, surgical or local treatment, or continuous medication;
- History of previous arterial or venous thromboembolic events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary artery embolism, deep vein thrombosis, or any other serious thromboembolism;
- Use of aspirin (>325 mg/day) or other drugs known to inhibit platelet function such as dipyridamole or clopidogrel for 10 consecutive days within 2 weeks prior to enrollment;
- Uncontrolled hypertension, systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy;
- Symptomatic congestive heart failure (New York Heart Association class II-IV); Symptomatic or poorly controlled arrhythmias; History of congenital long QT syndrome or corrected QT (QTc) > 500 ms at screening;
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- Diagnosis of other malignant tumors within 5 years prior to enrollment;
- Pregnant or lactating women or subjects planning to have a baby during the study period;
- Accompanied with other uncontrolled co-morbidities;
- Co-infection with HIV, known syphilis infection requiring treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: Prediction of Microvascular Invasion by Radiomics Based on Pre-treatment Magnetic Resonance Imaging (MRI) for Guiding Treatment of Barcelona Clinic Liver Cancer (BCLC) Stage B Hepatocellular Carcinoma (HCC): A Prospective Cohort Study
The goal of this observational study is to explore the role of prediction of microvascular invasion by radiomics based on pre-treatment magnetic resonance imaging for guiding treatment of Barcelona Clinic Liver Cancer stage B hepatocellular carcinoma.
- Conditions
- Radiomics, Hepatocellular Carcinoma (HCC), Transcatheter Arterial Chemoembolization (TACE), Microvascular Invasion (MVI), Multi-kinase Inhibitors (MKI)
- Being tested
- Sorafenib, Lenvatinib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
oral sorafenib
LenvatinibDrug
oral lenvatinib
| Study group | Role | What they receive |
|---|---|---|
| TACE+MKIs | Not described Receives: Drug: Sorafenib; Drug: Lenvatinib | |
| TACE | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS was defined as the interval from the date of enrollment to the date of death due to any cause or last follow-up.
Measured: From the date of enrollment to the date of death due to any cause or last follow-up, whichever came first, assessed up to 48 months
Progression-Free Survival (PFS)
PFS was defined as the interval from the date of enrollment to the date of disease progression or the date of death due to any cause or last follow-up, whichever occurred first.
Measured: From the date of enrollment to the date of disease progression or the date of death due to any cause or last follow-up, whichever came first, assessed up to 48 months
Secondary outcomes (2)
Tumor response
Assessed by enhanced CT or MR at baseline, every 6 weeks after treatment initiation, using RECIST 1.1 The assessment of tumor response was performed independently by two experienced radiologists who were blinded to the patient's clinical information, and any inconsistent assessment results were resolved by further consensus.
Measured: From the date of enrollment to the date of death due to any cause or last follow-up, whichever came first, assessed up to 48 months
Adverse events
The severity of adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE v5.0) .
Measured: From the date of enrollment to the date of death due to any cause or last follow-up, whichever came first, assessed up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start1 Jun 2019
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiomicsStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen-Wei Peng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889949
- Sponsor's protocol ID
- HCC 007
- Status last verified
- Jun 2023
- First submitted
- 22 May 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Microvascular Invasion by Radiomics Based on Pre-treatment Magnetic Resonance Imaging (MRI) for Guiding Treatment of Barcelona Clinic Liver Cancer (BCLC) Stage B Hepatocellular Carcinoma (HCC): A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05889949
- Acronym / sponsor ID
- HCC 007
- Conditions
- Radiomics, Hepatocellular Carcinoma (HCC), Transcatheter Arterial Chemoembolization (TACE), Microvascular Invasion (MVI), Multi-kinase Inhibitors (MKI)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 5 Jun 2023 (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 explore the role of prediction of microvascular invasion by radiomics based on pre-treatment magnetic resonance imaging for guiding treatment of Barcelona Clinic Liver Cancer stage B hepatocellular carcinoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE+MKIs | – | Drug: Sorafenib, Drug: Lenvatinib |
| TACE | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- BCLC stage B HCC patients
Key inclusion criteria (13 listed)
- Age 18-75 years;
- BCLC stage B HCC;
- Received no previous anti-cancer treatment;
- At least 1 measurable intrahepatic lesion based on the Response Evaluation Criteria in Solid Tumors criteria (RECIST) 1.1;
- Adequate hematological, liver, renal function:
Key exclusion criteria (10 listed)
- Acute or chronic active hepatitis B (HBV) or C (HCV) infection with HBV-DNA > 2000 IU/ml or 104 copies/ml; hepatitis C virus RNA > 103 copies/ml; HBsAg and anti-HCV antibody positive at the same time. Those who are below the above criteria after nucleoside based antiviral therapy may be enrolled;
- Life-threatening bleeding event within the past 3 months, including the need for blood transfusion, surgical or local treatment, or continuous medication;
- History of previous arterial or venous thromboembolic events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary artery embolism, deep vein thrombosis, or any other serious thromboembolism;
- Use of aspirin (>325 mg/day) or other drugs known to inhibit platelet function such as dipyridamole or clopidogrel for 10 consecutive days within 2 weeks prior to enrollment;
- Uncontrolled hypertension, systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sorafeniboral sorafenib | Drug | TACE+MKIs |
| Lenvatiniboral lenvatinib | Drug | TACE+MKIs |
Primary outcome
Overall Survival (OS)
Time frame: From the date of enrollment to the date of death due to any cause or last follow-up, whichever came first, assessed up to 48 months
OS was defined as the interval from the date of enrollment to the date of death due to any cause or last follow-up.
Progression-Free Survival (PFS)
Time frame: From the date of enrollment to the date of disease progression or the date of death due to any cause or last follow-up, whichever came first, assessed up to 48 months
PFS was defined as the interval from the date of enrollment to the date of disease progression or the date of death due to any cause or last follow-up, whichever occurred first.
2 secondary outcomes
Tumor response
Time frame: From the date of enrollment to the date of death due to any cause or last follow-up, whichever came first, assessed up to 48 months
Adverse events
Time frame: From the date of enrollment to the date of death due to any cause or last follow-up, whichever came first, assessed up to 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Radiomics and Hepatocellular Carcinoma (HCC), run by Sun Yat-sen University at 1 site in China.
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 13 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 7 Jun 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: From the date of enrollment to the date of death due to any cause or last follow-up, whichever came first, assessed up to 48 months). The study lists 2 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 7 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.