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Trial Title:
TIPS Combined With Lenvatinib and PD-1 Inhibitor for Advanced HCC With Main Trunk PVTT
NCT ID:
NCT06622031
Condition:
Hepatocellular Carcinoma
Portal Vein Tumor Thrombus
Systemic Therapy
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Thrombosis
Lenvatinib
Immune Checkpoint Inhibitors
Conditions: Keywords:
Advanced hepatocellular carcinoma
Lenvatinib
Sintilimab
Camrelizumab
Tislelizumab
Transjugular intrahepatic portosystemic shunt
Main trunk portal vein tumor thrombus
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
TIPS procedure
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Transjugular intrahepatic portosystemic shunt
Description:
A needle punctured the portal vein through the transjugular approach. After a successful
puncture, the parenchymal tract was dilated, and covered stents were introduced. The
specifications of the covered stents were 8 mm × 50 mm, 8 mm × 60 mm, 8 mm × 70 mm, and 8
mm × 80 mm. All of the diameters of the bare stents were 8 mm, and the lengths were 50-80
mm. The portal vein pressure was measured before and after shunt creation. After the
insertion of TIPS, all of the participants received a diuretic treatment and a
salt-limited diet.
Arm group label:
Transjugular intrahepatic portosystemic shunt
Other name:
TIPS
Intervention type:
Drug
Intervention name:
Lenvatinib
Description:
12 mg (body weight ≥60 kg) , 8 mg (body weight <60 kg
Arm group label:
Transjugular intrahepatic portosystemic shunt
Intervention type:
Drug
Intervention name:
PD-1 inhibitor
Description:
Tislelizumab (200mg intravenously every 3 weeks), Sintilimab (200mg intravenously every 3
weeks), Camrelizumab (200mg intravenously every 3 weeks)
Arm group label:
Transjugular intrahepatic portosystemic shunt
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, then the second is the tumor-caused death. It is vital
to prevent the portal hypertension by PVTT.
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. In this study, the investigators explore the TIPS combined with Lenvatinib and
PD-1 inhibitor for advanced hepatocellular carcinoma with main trunk portal vein tumor
thrombus. The investigators aim to add 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. with or without PVTT induced acute variceal bleeding;
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
Start date:
October 1, 2024
Completion date:
August 30, 2027
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/NCT06622031
