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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Chinese PLA General hospital
  Beijing, None Selected, China Recruiting

Study contacts

• Study coordinator: Qunfang Zhou, MD
• Email: zhouqun988509@163.com
• Phone: 86 19868000115

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.