NCT06624098 Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma
| NCT ID | NCT06624098 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-sen University |
| Condition | Advanced Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 22 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 22 participants in total. It began in 2024-10-01 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Feng Duan, MD
STUDY DIRECTOR
Chinese PLA General Hospital
Frequently Asked Questions
Who can join the NCT06624098 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06624098 currently recruiting?
Yes, NCT06624098 is actively recruiting participants. Contact the research team at zhouqun988509@163.com for enrollment information.
Where is the NCT06624098 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China.
Who is sponsoring the NCT06624098 clinical trial?
NCT06624098 is sponsored by Sun Yat-sen University. The principal investigator is Feng Duan, MD at Chinese PLA General Hospital. The trial plans to enroll 22 participants.
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