Actively Recruiting
Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma
Led by Sun Yat-sen University · Updated on 2024-10-02
22
Participants Needed
2
Research Sites
91 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
C
Chinese PLA General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of primary HCC confirmed histologically or clinically by American Association for the Study of Liver Diseases criteria
- Presence of PVTT with grade III-IV by Cheng's criteria
- PVTT-induced portal hypertension
- TIPS performed within 72 hours after endoscopic hemostasis
- Metastases limited to five sites and involvement of no more than two organs
- No more than five intrahepatic tumors
- Received Lenvatinib and PD-1 inhibitor as first-line systemic therapy
- Classified as Child-Pugh class A or B and ECOG performance status 0 to 2
- No history of other malignancies
- Agreed to participate in this clinical trial
- Blood counts and liver function within specified limits: hemameba ≥ 3.0 x10^9/L, neutrophil ≥ 1.5 x10^9/L, hemoglobin ≥ 10.0 g/L, platelet ≥ 100 x10^9/L, ALT, AST, bilirubin ≤ 1.5 times normal, GFR ≥ 60 ml/min
You will not qualify if you...
- Recurrent HCC
- PVTT at grade I-II by Cheng's criteria
- Age under 18 years or over 75 years
- Advanced HCC with more than five metastases
- More than five intrahepatic tumors
- No response to Lenvatinib
- Life expectancy less than 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Chinese PLA General hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
2
Chinese PLA General hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
Research Team
Q
Qunfang Zhou, MD
CONTACT
F
Feng Duan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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