SIRT for Potentially Resectable HCC

Trial Title: SIRT for Potentially Resectable HCC

NCT ID: NCT05994859

Condition: Hepatocellular Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular

Conditions: Keywords:
Hepatocellular Carcinoma
unresectable
selective internal radiation therapy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: SIRT
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.
Arm group label: SIRT

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).

Criteria for 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

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: February 9, 2027

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/NCT05994859