Lenvatinib, Sintilimab Plus SIRT for Unresectable HCC

Trial Title: Lenvatinib, Sintilimab Plus SIRT for Unresectable HCC

NCT ID: NCT05992584

Condition: Hepatocellular Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Lenvatinib

Conditions: Keywords:
Hepatocellular Carcinoma
Lenvatinib
Sintilimab
Yttrium-90

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Lenvatinib, sintilimab plus SIRT
Description: Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. QD and sintilimab 200mg I.V. q3w will be started at 3-7 days after the first SIRT. Treatment of sintilimab will last up to 24 months. Patients will be allowed to have lenvatilib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.
Arm group label: Len-Sin-SIRT

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).

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: The Second Affiliated Hospital of Guangzhou Medical University

Address:
City: Guangzhou
Zip: 510260
Country: China

Status: Recruiting

Contact:
Last name: Kangshun Zhu, Dr.

Phone: +86-20-34156205
Email: zhksh010@126.com

Investigator:
Last name: Kangshun Zhu, Dr.
Email: Principal Investigator

Investigator:
Last name: Mingyue Cai, Dr.
Email: Sub-Investigator

Start date: August 10, 2023

Completion date: August 9, 2026

Lead sponsor:
Agency: Second Affiliated Hospital of Guangzhou Medical University
Agency class: Other

Source: Second Affiliated Hospital of Guangzhou Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05992584