TACE Combined With Lenvatinib and PD-1 Inhibitor for Ruptured Hepatocellular Carcinoma
TACE Combined With Lenvatinib and PD-1 Inhibitor for Spontaneous Rupture of Hepatocellular Carcinoma: a Prospective Multicenter Study
Sun Yat-sen University
32 participants
Dec 13, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria10
- 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.
Exclusion Criteria7
- 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.
Interventions
Tislelizumab (200mg intravenously every 3 weeks), Sintilimab (200mg intravenously every 3 weeks), Camrelizumab (200mg intravenously every 3 weeks)
TACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then a combination of lipiodol (5-15 ml), lobaplatin (30-50 mg), and Pirarubicin (30-50 mg) was infused into each tumor. We defined technical success as complete embolization of the tumor-feeding artery resulting in no tumor staining observed by angiogram at the end of procedure.
(12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day
Locations(1)
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NCT06740370