Microvascular Invasion for Guiding Treatment of Barcelona Clinic Liver Cancer Stage B Hepatocellular Carcinoma

Hepatocellular Carcinoma (HCC) Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05889949
• Other study ID #: HCC 007
• Status: Active, not recruiting
• Start date: June 1, 2019
• Est. completion date: May 31, 2023

Study information

• Verified date: June 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma (HCC)
• Liver Neoplasms
• Radiomics

Intervention

Drug:
• Sorafenib
oral sorafenib
• Lenvatinib
oral lenvatinib

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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
Primary	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.	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	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.	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
Secondary	Adverse events	The severity of adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE v5.0) .	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