TIPS Combined With Lenvatinib and PD-1 Inhibitor for Advanced HCC With Main Trunk PVTT

Launched by SUN YAT-SEN UNIVERSITY · Sep 30, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with advanced liver cancer, specifically those whose cancer has spread into the portal vein, which can lead to serious complications like bleeding. The study is testing the combination of two medications, Lenvatinib and a PD-1 inhibitor, along with a procedure called TIPS (Transjugular Intrahepatic Portosystemic Shunt) to help improve patient outcomes and manage symptoms. The goal is to see if this combination can help prevent complications from portal vein tumor thrombus (PVTT) and improve survival rates.

To be eligible for this trial, participants must be adults aged between 18 and 75 years with a confirmed diagnosis of primary liver cancer and severe PVTT. They should have limited metastases (spread of cancer) and be in relatively good health, classified as either Child-Pugh class A or B, which indicates their liver function is stable. Participants will receive the new treatment and will be closely monitored throughout the trial to assess how well it works and to manage any side effects. This trial is currently recruiting participants and aims to find better treatments for a challenging condition.

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. with or without PVTT induced acute variceal bleeding;
• • 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.