Actively Recruiting
TIPS Combined With Lenvatinib and PD-1 Inhibitor for Advanced HCC With Main Trunk PVTT
Led by Sun Yat-sen University · Updated on 2025-01-13
42
Participants Needed
1
Research Sites
151 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, then the second is the tumor-caused death. It is vital to prevent the portal hypertension by PVTT.
CONDITIONS
Official Title
TIPS Combined With Lenvatinib and PD-1 Inhibitor for Advanced HCC With Main Trunk PVTT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of primary HCC confirmed histologically or clinically
- Presence of PVTT with III-IV grade by Cheng's criteria
- PVTT-induced portal hypertension
- With or without PVTT-induced acute variceal bleeding
- Limited metastases: no more than five sites and involvement of no more than two organs
- No more than five intrahepatic tumors
- Receiving Lenvatinib and PD-1 inhibitor as first-line systemic therapy
- Classified as Child-Pugh class A or B
- ECOG performance status of 0 to 2
- No history of other malignancies
- Agree to participate in the clinical trial
- Blood counts and liver/kidney function within specified limits (e.g., hemameba ≥3.0 x10^9/L, neutrophil ≥1.5 x10^9/L, hemoglobin ≥10.0 g/L, platelets ≥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 I-II grade by Cheng's criteria
- Age under 18 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: 1 location
1
Chinese PLA General hospital
Beijing, None Selected, 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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