SIRT for Potentially Resectable HCC

• Sponsor: Second Affiliated Hospital of Guangzhou Medical University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05994859
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 42
• Patients Per Site Per Month: 0.8

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Procedure: SIRT	N/A

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).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Y-90 Selective Internal Radiation Therapy for Potentially Resectable Hepatocellular Carcinoma: a Prospective, Single Arm Trial
• Anticipated Study Start Date: Aug 10, 2023
• Anticipated Primary Completion Date: Aug 9, 2026
• Anticipated Study Completion Date: Feb 9, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SIRT Treatment with SIRT.	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.

Outcome Measures

Primary Outcome Measures

1. Success rate of conversion to resection [3 years]

   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

1. Objective response rate (ORR) [3 years]

   The percentage of patients who have a best overall tumor response rating of complete response (CR) or partial response (PR)

2. Disease control rate (DCR) [3 years]

   The percentage of patients who have a tumor response rating of CR, PR, or stable disease (SD)

3. Progression-free survival (PFS) [3 years]

   The time between the first treatment and the first occurrence of disease progression (PD) or death from any cause, whichever occurs first

4. Time to progression (TTP) [3 years]

   the time interval from first treatment to the first occurrence of disease progression

5. Duration of response (DOR) [3 years]

   the time from initial objective response (CR or PR) until PD or death, whichever occurs first

6. Overall survival (OS) [3 years]

   The time from initiation of treatment until the date of death from any cause

7. Adverse Events (AEs) [3 years]

   Number of patients with AEs assessed by NCI CTCAE v5.0.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China	510260

Sponsors and Collaborators

• Second Affiliated Hospital of Guangzhou Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital of Guangzhou Medical University
• ClinicalTrials.gov Identifier: NCT05994859
• Other Study ID Numbers: MIIR-15
• First Posted: Aug 16, 2023
• Last Update Posted: Aug 16, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Second Affiliated Hospital of Guangzhou Medical University: Hepatocellular Carcinoma; unresectable; selective internal radiation therapy
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Hepatocellular

Study Results

No Results Posted as of Aug 16, 2023