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TIPS Combined With Lenvatinib and PD-1 Inhibitor for Advanced HCC With Main Trunk PVTT
RECRUITINGN/ASponsored by Sun Yat-sen University
Actively Recruiting
PhaseN/A
SponsorSun Yat-sen University
Started2024-10-01
Est. completion2026-12-01
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06622031
Summary
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, then the second is the tumor-caused death. It is vital to prevent the portal hypertension by PVTT.
Eligibility
Age: 18 Years – 75 YearsHealthy volunteers accepted
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.
Conditions6
CancerHepatocellular CarcinomaLiver CancerLiver DiseasePortal Vein Tumor ThrombusSystemic Therapy
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Actively Recruiting
PhaseN/A
SponsorSun Yat-sen University
Started2024-10-01
Est. completion2026-12-01
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06622031