Advanced Hepatocellular Carcinoma, Variceal Bleeding
Conditions
Keywords
Advanced hepatocellular carcinoma, Variceal bleeding, Therapeutic endoscopy, Transjugular intrahepatic portosystemic shunt
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.
Interventions
PROCEDUREEarly TIPS
TIPS was performed within 72 hours after the endoscopic hemostasis.
Sponsors
Chinese PLA General Hospital
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
TIPS was performed within 72 hours after variceal bleeding.
Intervention model description
Early transjugular intrahepatic portosystemic shunt (TIPS) within 72 hours after acute variceal bleeding.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of technical success | 3 months | Patients did not occur gastrointestinal hemorrhage and the stent unobstructed 3 months after TIPS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactQunfang Zhou, MD
Backup ContactFeng Duan, MD
Outcome results
None listed