SIRT for Potentially Resectable HCC

September 12, 2023 updated by: Second Affiliated Hospital of Guangzhou Medical University

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mingyue Cai, Dr.
  • Phone Number: +86-20-34156205
  • Email: cai020@yeah.net

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510260
        • Recruiting
        • The Second Affiliated Hospital of Guangzhou Medical University
        • Contact:
        • Principal Investigator:
          • Kangshun Zhu, Dr.
        • Sub-Investigator:
          • Mingyue Cai, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of conversion to resection
Time Frame: 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
3 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2023

Primary Completion (Estimated)

August 9, 2026

Study Completion (Estimated)

February 9, 2027

Study Registration Dates

First Submitted

August 9, 2023

First Submitted That Met QC Criteria

August 9, 2023

First Posted (Actual)

August 16, 2023

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIIR-15

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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