SIRT for Potentially Resectable HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

Y-90 Selective Internal Radiation Therapy for Potentially Resectable Hepatocellular Carcinoma: a Prospective, Single Arm Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05994859
• Other study ID #: MIIR-15
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2023
• Est. completion date: February 9, 2027

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 Y-90 selective internal radiation therapy (SIRT) in patients with potentially resectable hepatocellular carcinoma (HCC).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: February 9, 2027
• Est. primary completion date: August 9, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• SIRT
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.

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	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	3 years
Secondary	Objective response rate (ORR)	The percentage of patients who have a best overall tumor response rating of complete response (CR) or partial response (PR)	3 years
Secondary	Disease control rate (DCR)	The percentage of patients who have a tumor response rating of CR, PR, or stable disease (SD)	3 years
Secondary	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	3 years
Secondary	Time to progression (TTP)	the time interval from first treatment to the first occurrence of disease progression	3 years
Secondary	Duration of response (DOR)	the time from initial objective response (CR or PR) until PD or death, whichever occurs first	3 years
Secondary	Overall survival (OS)	The time from initiation of treatment until the date of death from any cause	3 years
Secondary	Adverse Events (AEs)	Number of patients with AEs assessed by NCI CTCAE v5.0.	3 years