Combining Biomarkers (AFP, AFP-L3, and PIVKA-II) and Image Tools for Early Detection of Hepatocellular Carcinoma

Launched by KOREA UNIVERSITY · May 30, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating a combination of blood tests and imaging scans to detect liver cancer (specifically hepatocellular carcinoma) early in patients who have liver cirrhosis. Liver cirrhosis is a serious condition where the liver becomes severely damaged, making patients at higher risk for developing liver cancer. The study will use three specific blood tests—AFP, AFP-L3, and PIVKA-II—along with abdominal ultrasounds or CT scans to see how effectively they can identify cancer in its early stages. Participants will undergo these tests every six months.

To be eligible for the trial, participants need to be between 19 and 75 years old and have a diagnosis of liver cirrhosis based on certain medical criteria. They should also expect to live for at least one more year. The trial is open to both men and women. Those who join can expect regular check-ups and testing as part of the study, which aims to improve early detection of liver cancer in high-risk patients. It’s important to note that individuals with a history of liver cancer, certain liver conditions, or specific health issues may not qualify for participation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Patients with liver cirrhosis meeting one of the followings:
• • i. Histologically confirmed liver cirrhosis ii. Imaging findings with liver cirrhosis (liver surface undulation, irregularity, or nodularity by US, CT, or MRI) plus one of followings: liver stiffness measurement ≥ 12.5 kilopascal, esophago-gastric varices, thrombocytopenia (\<120,000/mm3), hypoalbuminemia (\<3.5 g/dL), splenomegaly ≥12 cm) iii. Imaging findings with liver cirrhosis together with biomarkers suggesting liver cirrhosis (APRI ≥2.0 or fibrosis-4 ≥3.6) iv. Imaging findings with liver cirrhosis with history of hepatic decompensation (ascites, esophago-gastric variceal bleeding, jaundice, hepatic encephalopathy))
• • Expected survival more than 1 year
• • Child Pugh score 5-10 at the time of enrollment
• • Serum creatinine ≤1.5mg/dL
• • Age between 19 and 75 years old
• • No significant underlying medical illness affecting patient's survival
• • Patients available for regular follow-up according to the study protocol
• Exclusion Criteria:
• • History of HCC
• • AFP \>20 ng/mL
• • Hepatic nodule ≥ 1 cm by US or CT Exceptionally, nodules showing characteristic features of benign lesion such as hemangioma or pathologically conformed benign lesion are permitted for study inclusion.
• • Hepatic nodule less than 1 cm on US but imaging findings suggesting HCC by contrast enhanced US, CT, or MRI
• • Child-Pugh score ≥ 11
• • History of liver transplantation
• • Expecting liver transplantation within 1 year
• • Hypersensitivity on CT contrast dye
• • Any contraindication for CT
• • Not able to perform abdominal US
• • Other uncontrolled malignancy
• • Patients taking warfarin