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

NCT05889949 | Unknown FDA Drug

• 1 other identifier: HCC 007
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiomics; Hepatocellular Carcinoma (HCC); Transcatheter Arterial Chemoembolization (TACE); Microvascular Invasion (MVI); Multi-kinase Inhibitors (MKI)

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Tumor response

  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

  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

Study Arms (2)

TACE+MKIs

Drug: Sorafenib; Drug: Lenvatinib

TACE

Interventions

Sorafenib DRUG

oral sorafenib

TACE+MKIs

Lenvatinib DRUG

oral lenvatinib

TACE+MKIs

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

BCLC stage B HCC patients

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib; lenvatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 5, 2023
• Study Start: June 1, 2019
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-06

Locations

CN (1)