Clinical trial NCT05889949: Microvascular Invasion for Guiding Treatment of Barcelona Clinic Liver Cancer Stage B Hepatocellular Carcinoma
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Radiomics
Hepatocellular Carcinoma (HCC)
Transcatheter Arterial Chemoembolization (TACE)
Microvascular Invasion (MVI)
Multi-kinase Inhibitors (MKI)
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: BCLC stage B HCC patients

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: 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
measure: Progression-Free Survival (PFS)
timeFrame: 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:
measure: Tumor response
timeFrame: 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
measure: Adverse events
timeFrame: 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
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: