Early treatment for advanced liver cancer with a specific procedure

Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma With Main Trunk Portal Vein Tumor Thrombus Induced Gastrointestinal Bleeding: a Multicenter Phase II Study

This study is testing if an early procedure called TIPS can help people with advanced liver cancer who have serious bleeding problems feel better and get ready for other treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 22 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: Lenvatinib
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT06624098 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of early transjugular intrahepatic portosystemic shunt (TIPS) in patients with advanced hepatocellular carcinoma (HCC) who experience acute variceal bleeding due to portal hypertension caused by portal vein tumor thrombus (PVTT). The intervention aims to alleviate portal pressure and reduce the risk of gastrointestinal hemorrhage, thereby providing an opportunity for systemic therapy. Participants will undergo TIPS within 72 hours after endoscopic hemostasis, and the study seeks to provide clinical evidence for this treatment approach in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with primary HCC with high-grade PVTT, experiencing portal hypertension, and who have not had prior malignancies.

Not a fit: Patients with recurrent HCC or those with lower-grade PVTT may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of gastrointestinal bleeding in patients with advanced liver cancer, potentially improving survival rates.

How similar studies have performed: Previous studies have shown success with early TIPS in cirrhosis-induced portal hypertension, but this specific application for PVTT-induced portal hypertension is less established.

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.

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• Chinese PLA General hospital — Beijing, Beijing Municipality, China (Recruiting)
• Chinese PLA General hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Qunfang Zhou, MD

Conditions Advanced Hepatocellular Carcinoma; Variceal Bleeding; Advanced hepatocellular carcinoma; Variceal bleeding; Therapeutic endoscopy; Transjugular intrahepatic portosystemic shunt