Clinical trial · Interventional
Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma
Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma With Main Trunk Portal Vein Tumor Thrombus Induced Gastrointestinal Bleeding: a Multicenter Phase II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
| Variceal Bleeding | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Early TIPS | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Early transjugular intrahepatic portosystemic shunt (TIPS)
- description
- TIPS was performed within 72 hours after the endoscopic hemostasis.
- interventionNames
- Procedure: Early TIPS
Primary outcomes (1)
- measure
- Rates of technical success
- timeFrame
- 3 months
- description
- Patients did not occur gastrointestinal hemorrhage and the stent unobstructed 3 months after TIPS.
Secondary outcomes (5)
- measure
- Rates of gastrointestinal hemorrhage
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
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