Lenvatinib, Sintilimab Plus SIRT for Unresectable HCC

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05992584
• Other study ID #: MIIR-14
• Status: Recruiting
• Phase: Phase 2
• Start date: August 10, 2023
• Est. completion date: August 9, 2026

Study information

• Verified date: August 2023
• Source: Second Affiliated Hospital of Guangzhou Medical University
• Contact: Mingyue Cai, Dr.
• Phone: +86-20-34156205
• Email: cai020[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 9, 2026
• Est. primary completion date: January 9, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Lenvatinib, sintilimab plus SIRT
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.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS) according to mRECIST	The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.	2.5 years
Secondary	Progression free survival (PFS) according to RECIST 1.1	The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.	2.5 years
Secondary	Objective response rate (ORR)	The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR) according to mRECIST and RECIST 1.1	2.5 years
Secondary	Disease control rate (DCR)	The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD) according to mRECIST and RECIST 1.1	2.5 years
Secondary	Overall survival (OS)	The time from initiation of treatment until the date of death from any cause.	2.5 years
Secondary	Adverse Events (AEs)	Number of patients with AEs assessed by NCI CTCAE v5.0.	2.5 years