Actively Recruiting
Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma With Main Trunk Portal Vein Tumor Thrombus Induced Gastrointestinal Bleeding: a Multicenter Phase II Study
Led by Sun Yat-sen University · Updated on 2024-10-02
22
Participants Needed
2
Research Sites
26 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
Researchers are investigating advanced hepatocellular carcinoma (HCC) with main trunk portal vein tumor thrombus (PVTT), a serious condition often leading to poor outcomes due to portal hypertension causing gastrointestinal bleeding. This study aims to provide clinical evidence on the use of early transjugular intrahepatic portosystemic shunt (TIPS) within 72 hours after acute variceal bleeding to reduce portal pressure and bleeding risk in this patient group. The study involves performing early TIPS within 72 hours after endoscopic hemostasis to alleviate portal hypertension caused by PVTT. Patients included have advanced HCC with certain limits on tumor number and metastases, and receive first-line systemic therapies such as Lenvatinib and PD-1 inhibitors. The procedure is studied to see if it can prevent bleeding and improve survival outcomes. Participants will be monitored for technical success of the TIPS procedure at 3 months, rates of gastrointestinal bleeding at 6 months, and progression-free and overall survival up to 12 months. Researchers will also assess tumor response and record any adverse events during the 12-month follow-up. The total study period includes treatment and outcome assessments to evaluate the safety and effects of early TIPS in this specific HCC population.
CONDITIONS
Brief Title
Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of primary hepatocellular carcinoma confirmed histologically or clinically
- Presence of portal vein tumor thrombus (PVTT) grade III or IV by Cheng's criteria
- PVTT causing portal hypertension
- Ability to have TIPS performed within 72 hours after endoscopic hemostasis
- Limited metastases with no more than five sites and involvement of no more than two organs
- No more than five intrahepatic tumors
- Receipt of Lenvatinib and PD-1 inhibitor as first-line systemic therapy
- Classified as Child-Pugh class A or B with 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
You will not qualify if you...
- Recurrent hepatocellular carcinoma
- Portal vein tumor thrombus (PVTT) grade I or II by Cheng's criteria
- Age younger than 18 years or older than 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure performed within 72 hours after endoscopic hemostasis
Participants undergo the early transjugular intrahepatic portosystemic shunt (TIPS) procedure within 72 hours after endoscopic hemostasis to reduce portal hypertension and risk of gastrointestinal bleeding.
1 procedure visit plus follow-up visits as per clinical care
Duration - Up to 12 months
Participants are monitored for technical success, gastrointestinal hemorrhage, progression-free survival, overall survival, and adverse events after treatment.
Regular follow-up visits up to 12 months
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
F
Feng Duan, MD
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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