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New treatment option for Hepatocellular Carcinoma
Official title TIPS Combined With Lenvatinib and PD-1 Inhibitor for Advanced HCC With Main Trunk PVTT
ClinicalTrials.gov ID: NCT06622031
What this study is testing
What is Lenvatinib?
Lenvatinib is an investigational medicine, being studied as a potential treatment for hepatocellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver...
- 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;
You likely can't join if
- recurrent HCC;
- PVTT at I-II grade by Cheng's criteria;
- age \ 75 years;
- advanced HCC with more than five metastases;
- Number of Intrahepatic tumors were more than five;
- no response to Lenvatinib;
See the full eligibility criteria
- 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.
- recurrent HCC;
- PVTT at I-II grade by Cheng's criteria;
- age \ 75 years;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, None Selected, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, None Selected, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.