Clinical trial NCT05992584: Lenvatinib, Sintilimab Plus SIRT for Unresectable HCC
Official title: Lenvatinib, Sintilimab Plus Y-90 Selective Internal Radiation Therapy for Patients With Unresectable Intermediate-advanced Hepatocellular Carcinoma: a Prospective, Single-center, Single Arm Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
Lenvatinib
Sintilimab
Yttrium-90
Lead sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Progression free survival (PFS) according to mRECIST
timeFrame: 2.5 years
Secondary outcomes:
measure: Progression free survival (PFS) according to RECIST 1.1
timeFrame: 2.5 years
measure: Objective response rate (ORR)
timeFrame: 2.5 years
measure: Disease control rate (DCR)
timeFrame: 2.5 years
measure: Overall survival (OS)
timeFrame: 2.5 years
measure: Adverse Events (AEs)
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References: