TACE Combined With Lenvatinib and PD-1 Inhibitor for Ruptured Hepatocellular Carcinoma

Sun Yat-sen University

Status: Enrolling

Conditions: Anti-PD1 Antibody; Hepatocellular Carcinoma; Lenvatinib; Transcatheter Arterial Chemoembolization

Treatments: Drug: PD-1 Inhibitors; Procedure: TACE; Drug: Lenvatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT06740370

Liver Projiect 14

Details and patient eligibility

About

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.

Full description

Spontaneous rupture of HCC is a life-threatening complication. HCC rupture is considerably higher in China. The tumor size in ruptured HCC is significantly greater than that in non-ruptured HCC. In the acute phase, hemostasis is the first concern and then tumor treatment is secondary. TACE can effectively induce hemostasis. Conservative treatment is usually system therapy for unresectable ruptured HCC. Thus, we conduct this multicenter single arm study to explore the efficacy, safety of TACE combined lenvatinib and PD-1 inhibitor for unresectable ruptured HCC. This study focuses on the efficacy of TACE combined with lenvatinib and PD-1 inhibitor as first-line therapy.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

TACE plus Lenvatinib and PD-1 inhibitor

Experimental group

Description:

TACE was first performed, then Lenvatinib and PD-1 inhibitor were administered within seven days.

Treatment:

Drug: Lenvatinib

Procedure: TACE

Drug: PD-1 Inhibitors