Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma

Launched by SUN YAT-SEN UNIVERSITY · Oct 1, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a treatment called early transjugular intrahepatic portosystemic shunt (TIPS) for patients with advanced liver cancer known as hepatocellular carcinoma (HCC). Specifically, it focuses on patients who have a blockage in the main vein leading to the liver due to their cancer, which can cause dangerous bleeding. The goal is to see if performing TIPS within 72 hours after a bleeding episode can improve outcomes for these patients.

To be eligible for this trial, participants must have a confirmed diagnosis of primary HCC with a specific type of vein blockage, limited metastases (cancer spread), and must have already received certain first-line treatments. They should also be between 65 and 75 years old and have a good level of health overall. If you join the trial, you will receive the TIPS procedure along with close monitoring and support from the medical team. This trial is currently recruiting participants and aims to provide more effective care options for those facing advanced liver cancer and its complications.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;
• • 2. presence of PVTT with III-IV grade by Cheng's criteria;
• • 3. having PVTT induced portal hypertension;
• • 4. TIPS was performed within 72 hours after the endoscopic hemostasis;
• • 5. metastases with limited five sites and no more two organs involved;
• • 6. number of Intrahepatic tumors were no more than five;
• • 7. receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy;
• • 8. classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;
• • 9. no history of other malignancies;
• • 10. agreed to participated in this clinical trial;
• • 11. Hemameba ≥3.0 x109/L, neutrophil ≥1.5x109/L, hemoglobin≥10.0 g/L, platelet≥100x 109/L, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml/min.
• Exclusion Criteria:
• • 1. recurrent HCC;
• • 2. PVTT at I-II grade by Cheng's criteria;
• • 3. age \< 18 years or \> 75 years;
• • 4. advanced HCC with more than five metastases;
• • 5. Number of Intrahepatic tumors were more than five;
• • 6. no response to Lenvatinib;
• • 7. life expectancy less than 3 months.