Microvascular Invasion for Guiding Treatment of Barcelona Clinic Liver Cancer Stage B Hepatocellu… (NCT05889949) | Clinical Trial Compass
UnknownNot Applicable
Microvascular Invasion for Guiding Treatment of Barcelona Clinic Liver Cancer Stage B Hepatocellular Carcinoma
China200 participantsStarted 2019-06-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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;
✕. 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;
What they're measuring
1
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
2
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
✕. 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;
✕. 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;