Combining TIPS with Lenvatinib and PD-1 inhibitors for advanced liver cancer with portal vein tumor thrombus

Transjugular Intrahepatic Portosystemic Shunt Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma With Main Trunk Portal Vein Tumor Thrombus: a Multicenter Phase II Study

This study is testing if combining a special procedure with two cancer treatments can help people with advanced liver cancer and a serious blood clot in the portal vein feel better and have better results.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (other)
• Drugs / interventions: Lenvatinib
• Locations: 1 site (Beijing, None Selected)
• Trial ID: NCT06622031 on ClinicalTrials.gov

What this trial studies

This study investigates the use of transjugular intrahepatic portosystemic shunt (TIPS) in conjunction with Lenvatinib and PD-1 inhibitors for patients suffering from advanced hepatocellular carcinoma (HCC) with main trunk portal vein tumor thrombus (PVTT). The primary goal is to alleviate portal hypertension caused by PVTT, which is a significant factor leading to gastrointestinal hemorrhage and poor prognosis. By reducing portal pressure, the study aims to create a safer environment for systemic therapy, potentially improving patient outcomes. The study will gather clinical evidence to support this combined treatment approach for this specific subtype of advanced HCC.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with primary HCC and grade III-IV PVTT, who are classified as Child-Pugh class A or B.

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

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of gastrointestinal hemorrhage and improve survival rates for patients with advanced HCC and PVTT.

How similar studies have performed: While this approach is innovative, similar studies combining systemic therapies with interventions to manage portal hypertension have shown promise, suggesting potential for success.

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.

Where this trial is running

Beijing, None Selected

• Chinese PLA General hospital — Beijing, None Selected, China (RECRUITING)

Study contacts

• Study coordinator: Qunfang Zhou, MD

Conditions: Hepatocellular Carcinoma, Portal Vein Tumor Thrombus, Systemic Therapy, Advanced hepatocellular carcinoma, Lenvatinib, Sintilimab, Camrelizumab, Tislelizumab