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Trial Title:
Microvascular Invasion for Guiding Treatment of Barcelona Clinic Liver Cancer Stage B Hepatocellular Carcinoma
NCT ID:
NCT05889949
Condition:
Radiomics
Hepatocellular Carcinoma (HCC)
Transcatheter Arterial Chemoembolization (TACE)
Microvascular Invasion (MVI)
Multi-kinase Inhibitors (MKI)
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Sorafenib
Lenvatinib
Study type:
Observational [Patient Registry]
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Sorafenib
Description:
oral sorafenib
Arm group label:
TACE+MKIs
Intervention type:
Drug
Intervention name:
Lenvatinib
Description:
oral lenvatinib
Arm group label:
TACE+MKIs
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.
Criteria for eligibility:
Study pop:
BCLC stage B HCC patients
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. Age 18-75 years;
2. BCLC stage B HCC;
3. Received no previous anti-cancer treatment;
4. At least 1 measurable intrahepatic lesion based on the Response Evaluation Criteria
in Solid Tumors criteria (RECIST) 1.1;
5. Adequate hematological, liver, renal function:
1. absolute neutrophil count ≥ 1.5×109/L;
2. platelet count ≥ 100×109/L;
3. hemoglobin concentration ≥ 90 g/L;
4. albumin ≥ 28 g/L;
5. total bilirubin < 1.5 times the upper limit of normal;
6. alanine aminotransferase and aspartate aminotransferase < 5 times the upper
limit of normal;
7. 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;
6. Life expectancy of at least 3 months.
Exclusion Criteria:
1. 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;
2. Life-threatening bleeding event within the past 3 months, including the need for
blood transfusion, surgical or local treatment, or continuous medication;
3. 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;
4. 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;
5. Uncontrolled hypertension, systolic blood pressure > 140 mmHg or diastolic blood
pressure > 90 mmHg after optimal medical treatment, history of hypertensive crisis
or hypertensive encephalopathy;
6. 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;
7. Diagnosis of other malignant tumors within 5 years prior to enrollment;
8. Pregnant or lactating women or subjects planning to have a baby during the study
period;
9. Accompanied with other uncontrolled co-morbidities;
10. Co-infection with HIV, known syphilis infection requiring treatment.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Start date:
June 1, 2019
Completion date:
May 31, 2023
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05889949
