Hepatocellular Carcinoma, Portal Hypertension
Conditions
Keywords
hepatocellular carcinoma, transarterial chemoembolization, portal hypertension, non-invasive imaging assessment, deep learning
Brief summary
This study aims to evaluate the impact of non-invasive CT-based Hepatic Venous Pressure Gradient (HVPG) assessment on prognosis of hepatocellular carcinoma (HCC) patients treated with transarterial chemoembolization (TACE).
Detailed description
Hepatocellular carcinoma (HCC) is the sixth most common cancer worldwide and the second leading cause of cancer-related deaths globally. Transarterial chemoembolization (TACE) is recommended as standard therapy for intermediate-stage HCC according to the current guidelines and is also the most widely used in advanced HCC in real-world practice. Portal hypertension increases the risk of hepatic decompensation, which impairs survival in patients with HCC. Clinically significant portal hypertension is defined as \>10 mmHg increase in the hepatic vein pressure gradient (HVPG), and the current gold standard for its assessment is direct measurement, through a transjugular approach. However, due to its invasive character and high effort, HVPG measurement is not a standard tool in the initial diagnostic evaluation of patients with HCC. This study aims to evaluate the impact of non-invasive CT-based Hepatic Venous Pressure Gradient (HVPG) assessment on prognosis of hepatocellular carcinoma (HCC) patients treated with transarterial chemoembolization (TACE).
Interventions
PROCEDURETACE ± Systemic therapy
TACE: conventional TACE (cTACE) or drug-eluting beads TACE (dTACE); Systemic therapy: programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) inhibitors, vascular endothelial growth factor -tyrosine kinase inhibitor (VEGF-TKI)/bevacizumab, PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab, radiotherapy or chemotherapy.
Sponsors
Zhongda Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology; 2. Received at least 1 TACE treatment； 3. Contrast-enhanced computed tomography (CECT) examination within 1 month before the first TACE treatment;
Exclusion criteria
1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible; 2. Eastern Cooperative Oncology Group - Performance Status (ECOG-PS) \> 2; 3. History of liver or spleen resection; 4. Loss to follow-up; 5. CECT image data was incomplete, unclear, or artifact occurred.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival(OS) | up to approximately 2 years | The OS is defined as the time from the initiation of any treatment to death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate(ORR) per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) | up to approximately 2 years | The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per mRECIST. |
| Progression free survival(PFS) per mRECIST | up to approximately 2 years | The PFS is defined as the time from the initiation of any treatment to the first documented progressive disease (according to mRECIST) or death due to any cause, whichever occurs first. |
Countries
China
Contacts
Primary ContactGao-Jun Teng, M.D.
Backup ContactYu-Qing Wang
Outcome results
None listed