Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma

Not Applicable

Recruiting

• Conditions: Advanced Hepatocellular Carcinoma; Variceal Bleeding
• Interventions: Procedure: Early TIPS

• Registration Number: NCT06624098
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-01
• Study First Submitted: 2024-10-01
• Study First Submitted QC: 2024-10-01
• Last Update Submitted: 2024-10-01
• Study First Posted: 2024-10-02
• Last Update Posted: 2024-10-02
• Primary Completion: 2025-12-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Early transjugular intrahepatic portosystemic shunt (TIPS)	Early TIPS	TIPS was performed within 72 hours after the endoscopic hemostasis.

Primary Outcome Measures

Name	Time	Method
Rates of technical success	3 months	Patients did not occur gastrointestinal hemorrhage and the stent unobstructed 3 months after TIPS.

Secondary Outcome Measures

Name	Time	Method
Rates of gastrointestinal hemorrhage	6 months	Patients occur gastrointestinal hemorrhage within 6 months after TIPS.
Progression-Free-Survival (PFS)	12 months	Progression was defined as progressive disease by independent radiologic review.
Overall survival (OS)	12 months	OS is the length of time from the date of inclusion until death from any cause.
Objective response rate (ORR)	12 months	ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response.
Adverse events	12 months	Safety will be evaluated according to the NCI CTCAE Version 4.03.

Trial Locations

Locations (1)

Chinese PLA General hospital; 🇨🇳 Beijing, Beijing, China