search
Back to results

Lenvatinib, Sintilimab Plus SIRT for Unresectable HCC

Primary Purpose

Hepatocellular Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Lenvatinib, sintilimab plus SIRT
Sponsored by
Second Affiliated Hospital of Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Lenvatinib, Sintilimab, Yttrium-90

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Len-Sin-SIRT

Arm Description

Lenvatinib, sintilimab plus SIRT

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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
Overall survival (OS)
The time from initiation of treatment until the date of death from any cause.
Adverse Events (AEs)
Number of patients with AEs assessed by NCI CTCAE v5.0.

Full Information

First Posted
August 7, 2023
Last Updated
September 12, 2023
Sponsor
Second Affiliated Hospital of Guangzhou Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT05992584
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2023 (Actual)
Primary Completion Date
January 9, 2026 (Anticipated)
Study Completion Date
August 9, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Guangzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular Carcinoma, Lenvatinib, Sintilimab, Yttrium-90

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Len-Sin-SIRT
Arm Type
Experimental
Arm Description
Lenvatinib, sintilimab plus SIRT
Intervention Type
Drug
Intervention Name(s)
Lenvatinib, sintilimab plus SIRT
Intervention 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.
Primary Outcome Measure Information:
Title
Progression free survival (PFS) according to mRECIST
Description
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
Time Frame
2.5 years
Secondary Outcome Measure Information:
Title
Progression free survival (PFS) according to RECIST 1.1
Description
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
Time Frame
2.5 years
Title
Objective response rate (ORR)
Description
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
Time Frame
2.5 years
Title
Disease control rate (DCR)
Description
The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD) according to mRECIST and RECIST 1.1
Time Frame
2.5 years
Title
Overall survival (OS)
Description
The time from initiation of treatment until the date of death from any cause.
Time Frame
2.5 years
Title
Adverse Events (AEs)
Description
Number of patients with AEs assessed by NCI CTCAE v5.0.
Time Frame
2.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mingyue Cai, Dr.
Phone
+86-20-34156205
Email
cai020@yeah.net
First Name & Middle Initial & Last Name or Official Title & Degree
Kangshun Zhu, Dr.
Phone
+86-20-34156205
Email
zhksh010@163.com
Facility Information:
Facility Name
The Second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kangshun Zhu, Dr.
Phone
+86-20-34156205
Email
zhksh010@126.com
First Name & Middle Initial & Last Name & Degree
Kangshun Zhu, Dr.
First Name & Middle Initial & Last Name & Degree
Mingyue Cai, Dr.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Lenvatinib, Sintilimab Plus SIRT for Unresectable HCC

We'll reach out to this number within 24 hrs