TACE Combined With Lenvatinib and PD-1 Inhibitor for Ruptured Hepatocellular Carcinoma
Recruiting now · Not applicable
Conditions studied: Hepatocellular Carcinoma, Transcatheter Arterial Chemoembolization, Anti-PD1 Antibody, Lenvatinib
In brief
Hepatocellular carcinoma (HCC) with spontaneous rupture is a potentially fatal complication and usually has poor prognosis. In most conditions, the tumors could not be radically moved. Then minimally therapy like transcatheter arterial chemoembolization (TACE) could effectively stanch the ruptured tumor and bleeding vessels. Then TACE combined the Lenvatinib and PD-1 inhibitor for this subtype HCC could effectively inhibit the tumor and improve the prognosis.
Key facts
- Study ID
- NCT06740370
- Run by
- Sun Yat-sen University
- People needed
- 32
- Starts
- 2024-12-13
- Expected to finish
- 2026-08-30
- Last updated by the study team
- 2025-08-14
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;
- presence of hemostasis in the enhanced CT scan;
- integrity of the tumor is disrupted and there is hematoma around the liver;
- receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy;
- transarterial artery chemoembolization (TACE) as local 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.
- life expectancy more than 3 months;
- 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.
You may not qualify if…
- recurrent HCC;
- non-ruptured HCC;
- Lenvatinib and PD-1 inhibitor treated with as second systemic therapy;
- age < 18 years or > 75 years;
- HCC with more than five metastases;
- History of hepatic encephalopathy and gastrointestinal bleeding
- life expectancy less than 3 months.
Where it is running
- Qunfang Zhou — Beijing, None Selected, China (enrolling)
Full record on ClinicalTrials.gov
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