Clinical trial NCT06624098: Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma
Official title: Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma With Main Trunk Portal Vein Tumor Thrombus Induced Gastrointestinal Bleeding: a Multicenter Phase II Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Advanced Hepatocellular Carcinoma
Variceal Bleeding
Keywords: Advanced hepatocellular carcinoma
Variceal bleeding
Therapeutic endoscopy
Transjugular intrahepatic portosystemic shunt
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
First posted: 2024-10-02
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Early transjugular intrahepatic portosystemic shunt (TIPS) within 72 hours after acute variceal bleeding.
Primary purpose: TREATMENT

Brief 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. Studies have proven that early transjugular intrahepatic portosystemic shunt (TIPS) with 72 hours after acute variceal bleeding is effective.

Detailed description: Portal hypertension by main trunk portal vein tumor thrombus (PVTT) is a severe disease. Patients usually die of gastrointestinal hemorrhage rather than tumor progression. It is vital to prevent the portal hypertension. Transjugular intrahepatic portosystemic shunt (TIPS) is an effective method to alleviate the portal pressure. Then the risk of gastrointestinal hemorrhage is decreased which provides an opportunity for system therapy. Studies have proven that early transjugular intrahepatic portosystemic shunt (TIPS) with 72 hours after acute variceal bleeding is effective for cirrhosis induced portal hypertension. However, the PVTT induced portal hypertension still needs clinical evidence. In this study, the investigators explore the early TIPS for advanced hepatocellular carcinoma with main trunk portal vein tumor thrombus induced acute variceal bleeding. The investigators aim to added clinical evidence for this subtype of advanced HCC.

Eligibility criteria: 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. TIPS was performed within 72 hours after the endoscopic hemostasis;
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.

Primary outcomes:
measure: Rates of technical success
timeFrame: 3 months
Secondary outcomes:
measure: Rates of gastrointestinal hemorrhage
timeFrame: 6 months
measure: Progression-Free-Survival (PFS)
timeFrame: 12 months
measure: Overall survival (OS)
timeFrame: 12 months
measure: Objective response rate (ORR)
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Feng Duan, MD
role: STUDY_DIRECTOR
References: