Lenvatinib, Sintilimab Plus SIRT for Unresectable HCC

Second Affiliated Hospital of Guangzhou Medical University

Status and phase

Enrolling

Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

Drug: Lenvatinib, sintilimab plus SIRT

Study type

Interventional

Funder types

Other

Identifiers

NCT05992584

MIIR-14

Details and patient eligibility

About

This study is conducted to evaluate the efficacy and safety of lenvatinib, sintilimab plus Y-90 selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC).

Full description

This is a single-center, prospective study to evaluate the efficacy and safety of lenvatinib, sintilimab plus SIRT (Len-Sin-SIRT) in patient with unresectable HCC.

30 patients with unresectable intermediate-advanced HCC (BCLC B/C stage) will be enrolled in this study. The patients will receive lenvatinib (body weight ≥60kg, 12mg; body weight <60kg, 8mg; P.O. QD) and sintilimab (200mg I.V. Q3W) at 3-7 days after SIRT. Sintilimab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Lenvatinib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first.

The primary end point of this study is Progression free survival (PFS) per mRECIST. The secondary endpoints are PFS per RECIST 1.1, objective response rate (ORR), disease control rate (DCR), overall survival (OS) and adverse events (AEs).

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Unresectable HCC (BCLC stage B/C) with diagnosis confirmed by histology/cytology or clinically
At least one measurable untreated lesion
Intrahepatic tumors can be treated with 1-2 session of SIRT
Child-Pugh score 5-7
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
Life expectancy of at least 3 months
Patients with active hepatitis B are allowed, but they need to receive antiviral treatment to achieve a HBV DNA<10^3 IU/mL
Patients with hepatitis C need to finish the anti-HCV treatment

Exclusion criteria

tumor extent ≥70% liver occupation
Tumor thrombus involving main portal vein or both the first left and right branch of portal vein
Vena cava invasion
Central nervous system metastasis
Metastatic disease that involves major airways or blood vessels
Patients who previously received hepatic arterial infusion chemotherapy (HAIC), transarterial chemoembolization (TACE), transarterial embolization (TAE), radiotherapy, systemic therapy, or immunotherapy for HCC
History of organ and cell transplantation
Prior esophageal and/or gastric varices bleeding
History of hepatic encephalopathy
Peripheral blood white blood cell count<3×10^9/L, platelet count<50×10^9/L
Prolongation of prothrombin time ≥ 4 seconds
Severe organ dysfunction (heart, lungs, kidneys)
History of malignancy other than HCC
HBsAg and anti-HCV antibody positive concurrently
Human immunodeficiency virus (HIV) infected