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Trial Title:
Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma
NCT ID:
NCT06624098
Condition:
Advanced Hepatocellular Carcinoma
Variceal Bleeding
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Hemorrhage
Conditions: Keywords:
Advanced hepatocellular carcinoma
Variceal bleeding
Therapeutic endoscopy
Transjugular intrahepatic portosystemic shunt
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Early transjugular intrahepatic portosystemic shunt (TIPS) within 72 hours after acute
variceal bleeding.
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
TIPS was performed within 72 hours after variceal bleeding.
Intervention:
Intervention type:
Procedure
Intervention name:
Early TIPS
Description:
TIPS was performed within 72 hours after the endoscopic hemostasis.
Arm group label:
Early transjugular intrahepatic portosystemic shunt (TIPS)
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chinese PLA General hospital
Address:
City:
Beijing
Zip:
100853
Country:
China
Status:
Recruiting
Contact:
Last name:
Qunfang Zhou, MD
Phone:
8619868000115
Email:
zhouqun988509@163.com
Contact backup:
Last name:
Feng Duan, MD
Phone:
8613910984586
Email:
duanfeng@vip.sina.com
Facility:
Name:
Chinese PLA General hospital
Address:
City:
Beijing
Zip:
100853
Country:
China
Status:
Recruiting
Contact:
Last name:
Qunfang Zhou, MD
Phone:
86 19868000115
Email:
zhouqun988509@163.com
Contact backup:
Last name:
Feng Duan, MD
Phone:
86 13910984586
Email:
duanfeng@vip.sina.com
Start date:
October 1, 2024
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Chinese PLA General Hospital
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06624098
