NCT06622031Recruiting
TIPS Combined With Lenvatinib and PD-1 Inhibitor for Advanced HCC With Main Trunk PVTT
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
Source: ClinicalTrials.gov · Last updated 13 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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, then the second is the tumor-caused death. It is vital to prevent the portal hypertension by PVTT.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 30 Sept 2024
- Start date
- 1 Oct 2024
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06622031
What you commit to
- Study type: Interventional
- Planned participants: 42
- From 1 Oct 2024 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- age \< 18 years or \> 75 years;
Other
- recurrent HCC;
- PVTT at I-II grade by Cheng's criteria;
- advanced HCC with more than five metastases;
- Number of Intrahepatic tumors were more than five;
- no response to Lenvatinib;
- life expectancy less than 3 months.
Who the study is looking for
- diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;
- presence of PVTT with III-IV grade by Cheng's criteria;
- having PVTT induced portal hypertension;
- with or without PVTT induced acute variceal bleeding;
- metastases with limited five sites and no more two organs involved;
- Number of Intrahepatic tumors were no more than five;
- receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy;
- classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;
- no history of other malignancies;
- agreed to participated in this clinical trial;
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.