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SIRT for Potentially Resectable HCC

Primary Purpose

Hepatocellular Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
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, unresectable, selective internal radiation therapy

Eligibility Criteria

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

Inclusion Criteria: HCC with diagnosis confirmed pathologically or clinically No pervious treatment for HCC At least one measurable intrahepatic target lesion Potentially resectable HCC: tumor(s) confined to the left/right hemiliver, with/without invasion to the unilateral branch of the portal vein and/or hepatic vein Disease amenable to SIRT (after evaluation) Child-Pugh Class A or without cirrhosis Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 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 Adequate organ and bone marrow function; the blood biochemical examination: platelet count ≥75×10^9/L, white blood cell count >3.0×10^9/L, absolute value of neutrophils >1.5×10^9/L, hemoglobin ≥85 g/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR<1.5 or PT/APTT normal range Life expectancy of at least 6 months Exclusion Criteria: Tumor involving main portal vein, bilateral branches of portal vein, or vena cava tumor extention beyond one lobe of the liver Bilobar tumor distribution Extrahepatic metastasis Decompensated liver function, including ascites, bleeding from esophageal and gastric varices, and/or hepatic encephalopathy Organ (heart, kidney) dysfunction HBsAg and anti-HCV antibody positive concurrently History of malignancy other than HCC Uncontrolled infection History of HIV History of organ and cell transplantation Patients with bleeding tendency

Sites / Locations

  • The Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SIRT

Arm Description

Treatment with SIRT.

Outcomes

Primary Outcome Measures

Success rate of conversion to resection
The proportion of patients with initially unresectable HCC who were evaluated by the surgical team as suitable for second-stage surgical resection after SIRT

Secondary Outcome Measures

Objective response rate (ORR)
The percentage of patients who have a best overall tumor response rating of complete response (CR) or partial response (PR)
Disease control rate (DCR)
The percentage of patients who have a tumor response rating of CR, PR, or stable disease (SD)
Progression-free survival (PFS)
The time between the first treatment and the first occurrence of disease progression (PD) or death from any cause, whichever occurs first
Time to progression (TTP)
the time interval from first treatment to the first occurrence of disease progression
Duration of response (DOR)
the time from initial objective response (CR or PR) until PD or death, whichever occurs first
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 9, 2023
Last Updated
September 12, 2023
Sponsor
Second Affiliated Hospital of Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05994859
Brief Title
SIRT for Potentially Resectable HCC
Official Title
Y-90 Selective Internal Radiation Therapy for Potentially Resectable Hepatocellular Carcinoma: a Prospective, 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
August 9, 2026 (Anticipated)
Study Completion Date
February 9, 2027 (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 Y-90 selective internal radiation therapy (SIRT) in patients with potentially resectable hepatocellular carcinoma (HCC).
Detailed Description
This is a bi-center, prospective study to evaluate the efficacy and safety of SIRT in patient with potentially resectable HCC. 35 patients with potentially resectable (initially unresectable) HCC will be enrolled in this study. The patients will receive 1-2 sessions of SIRT. If the patients have invasive tumors, extensive liver involvement or vascular invasion, systematic treatment will be added. If the patients are evaluated as resectable during follw-up, liver resection will be recommended. The primary end point of this study is success rate of conversion to resection. The secondary endpoints are objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), time to progression (TTP), duration of response (DOR), 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, unresectable, selective internal radiation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SIRT
Arm Type
Experimental
Arm Description
Treatment with SIRT.
Intervention Type
Procedure
Intervention Name(s)
SIRT
Intervention Description
The patients will receive 1-2 sessions of SIRT. If the patients have invasive tumors, extensive liver involvement or vascular invasion, systematic treatment will be added.
Primary Outcome Measure Information:
Title
Success rate of conversion to resection
Description
The proportion of patients with initially unresectable HCC who were evaluated by the surgical team as suitable for second-stage surgical resection after SIRT
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
The percentage of patients who have a best overall tumor response rating of complete response (CR) or partial response (PR)
Time Frame
3 years
Title
Disease control rate (DCR)
Description
The percentage of patients who have a tumor response rating of CR, PR, or stable disease (SD)
Time Frame
3 years
Title
Progression-free survival (PFS)
Description
The time between the first treatment and the first occurrence of disease progression (PD) or death from any cause, whichever occurs first
Time Frame
3 years
Title
Time to progression (TTP)
Description
the time interval from first treatment to the first occurrence of disease progression
Time Frame
3 years
Title
Duration of response (DOR)
Description
the time from initial objective response (CR or PR) until PD or death, whichever occurs first
Time Frame
3 years
Title
Overall survival (OS)
Description
The time from initiation of treatment until the date of death from any cause
Time Frame
3 years
Title
Adverse Events (AEs)
Description
Number of patients with AEs assessed by NCI CTCAE v5.0.
Time Frame
3 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: HCC with diagnosis confirmed pathologically or clinically No pervious treatment for HCC At least one measurable intrahepatic target lesion Potentially resectable HCC: tumor(s) confined to the left/right hemiliver, with/without invasion to the unilateral branch of the portal vein and/or hepatic vein Disease amenable to SIRT (after evaluation) Child-Pugh Class A or without cirrhosis Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 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 Adequate organ and bone marrow function; the blood biochemical examination: platelet count ≥75×10^9/L, white blood cell count >3.0×10^9/L, absolute value of neutrophils >1.5×10^9/L, hemoglobin ≥85 g/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR<1.5 or PT/APTT normal range Life expectancy of at least 6 months Exclusion Criteria: Tumor involving main portal vein, bilateral branches of portal vein, or vena cava tumor extention beyond one lobe of the liver Bilobar tumor distribution Extrahepatic metastasis Decompensated liver function, including ascites, bleeding from esophageal and gastric varices, and/or hepatic encephalopathy Organ (heart, kidney) dysfunction HBsAg and anti-HCV antibody positive concurrently History of malignancy other than HCC Uncontrolled infection History of HIV History of organ and cell transplantation Patients with bleeding tendency
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

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SIRT for Potentially Resectable HCC

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