RECRUITINGINTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 hemostasis in the enhanced CT scan; 3. integrity of the tumor is disrupted and there is hematoma around the liver; 4. receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy; 5. transarterial artery chemoembolization (TACE) as local therapy; 6. classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2; 7. no history of other malignancies. 8. life expectancy more than 3 months; 9. agreed to participated in this clinical trial; 10. Hemameba ≥3.0 x109/L, neutrophil ≥1.5x109/L, blood count (hemoglobin) at least 10.0 g/L, platelet count at least 100x 109/L, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml/min. Who Should NOT Join This Trial: 1. recurrent HCC; 2. non-ruptured HCC; 3. Lenvatinib and PD-1 inhibitor treated with as second systemic therapy; 4. age \< 18 years or \> 75 years; 5. HCC with more than five metastases; 6. History of hepatic encephalopathy and gastrointestinal bleeding 7. life expectancy less than 3 months. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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 hemostasis in the enhanced CT scan; 3. integrity of the tumor is disrupted and there is hematoma around the liver; 4. receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy; 5. transarterial artery chemoembolization (TACE) as local therapy; 6. classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2; 7. no history of other malignancies. 8. life expectancy more than 3 months; 9. agreed to participated in this clinical trial; 10. 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. non-ruptured HCC; 3. Lenvatinib and PD-1 inhibitor treated with as second systemic therapy; 4. age \< 18 years or \> 75 years; 5. HCC with more than five metastases; 6. History of hepatic encephalopathy and gastrointestinal bleeding 7. life expectancy less than 3 months.

Treatments Being Tested

PROCEDURE

TACE

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.

DRUG

Lenvatinib

(12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day

DRUG

PD-1 Inhibitors

Tislelizumab (200mg intravenously every 3 weeks), Sintilimab (200mg intravenously every 3 weeks), Camrelizumab (200mg intravenously every 3 weeks)

Locations (1)

Qunfang Zhou

Beijing, None Selected, China