Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma With Main Trunk Portal Vein Tumor Thrombus Induced Gastrointestinal Bleeding: a Multicenter Phase II Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;

• presence of PVTT with III-IV grade by Cheng's criteria;

• having PVTT induced portal hypertension;

• TIPS was performed within 72 hours after the endoscopic hemostasis;

• metastases with limited five sites and no more two organs involved;

• number of Intrahepatic tumors were no more than five;

• receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy;

• classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;

• no history of other malignancies;

⁃ agreed to participated in this clinical trial;

⁃ 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.

Locations
Other Locations
China
Chinese PLA General hospital
RECRUITING
Beijing
Chinese PLA General hospital
RECRUITING
Beijing
Contact Information
Primary
Qunfang Zhou, MD
zhouqun988509@163.com
86 19868000115
Backup
Feng Duan, MD
duanfeng@vip.sina.com
86 13910984586
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 22
Treatments
Experimental: Early transjugular intrahepatic portosystemic shunt (TIPS)
TIPS was performed within 72 hours after the endoscopic hemostasis.
Sponsors
Collaborators: Chinese PLA General Hospital
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov