Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma

Recruiting now · Not applicable

Conditions studied: Advanced Hepatocellular Carcinoma, Variceal Bleeding

In brief

Hepatocellular carcinoma (HCC) with main trunk portal vein tumor thrombus (PVTT) has poor prognosis. The main lethiferous factor is the upper gastrointestinal hemorrhage by PVTT-related portal hypertension. Studies have proven that early transjugular intrahepatic portosystemic shunt (TIPS) with 72 hours after acute variceal bleeding is effective.

Key facts

Study ID

NCT06624098

Run by

Sun Yat-sen University

People needed

22

Starts

2024-10-01

Expected to finish

2026-06-30

Last updated by the study team

2024-10-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;
• presence of PVTT with III-IV grade by Cheng's criteria;
• having PVTT induced portal hypertension;
• TIPS was performed within 72 hours after the endoscopic hemostasis;
• metastases with limited five sites and no more two organs involved;
• number of Intrahepatic tumors were no more than five;
• receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy;
• classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;
• no history of other malignancies;
• agreed to participated in this clinical trial;
• 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.

You may not qualify if…

• recurrent HCC;
• PVTT at I-II grade by Cheng's criteria;
• age < 18 years or > 75 years;
• advanced HCC with more than five metastases;
• Number of Intrahepatic tumors were more than five;
• no response to Lenvatinib;
• life expectancy less than 3 months.

Where it is running

• Chinese PLA General hospital — Beijing, Beijing Municipality, China (enrolling)
• Chinese PLA General hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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