Y-90 SIRT for Unresectable HCC Larger Than 7cm

January 26, 2025 updated by: Second Affiliated Hospital of Guangzhou Medical University

Y-90 Selective Internal Radiation Therapy for Unresectable Hepatocellular Carcinoma Larger Than 7cm: a Prospective, Single Arm Trial

This is a phase II clinical study to evaluate the efficacy and safety of SIRT in patients with HCC greater than 7 cm. After enrollment, patients received yttrium-90 selective internal radiation therapy. The primary endpoint of the study is objective reponse rate (ORR) as assessed by mRECIST. Secondary endpoints were: objective response rate (ORR) as assessed by RECIST 1.1, disease control rate (DCR), progression-free survival (PFS), time to response (TTR), duration of response (DOR), overall survival (OS), and safety (incidence and severity of adverse events).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

33

Phase

  • Phase 2

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:
        • Contact:
        • Contact:
          • Kangshun Zhu, Dr.
      • Guangzhou, Guangdong, China, 510260
        • Not yet recruiting
        • The second Affiliated Hospital of Guangzhou Medical University
        • Contact:
        • Contact:
          • Kangshun Zhu, 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:

  • Pathologically confirmed or clinically diagnosed HCC
  • Unresectable HCC as assessed by a team of surgeons
  • The largest tumor size > 7 cm
  • Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment
  • At least one measurable intrahepatic target lesion
  • Appropriate for SIRT treatment after evaluation (including SPECT/CT evaluation after arterial perfusion with 99Tc-MAA)
  • Child-Pugh score ≤ 7
  • ECOG PS ≤ 1
  • Adequate organ and hematologic function with platelet count ≥75×10^9/L, leukocyte >3.0×10^9/L, Neutrophil count ≥1.5×10^9/L, haemoglobin ≥85 g/L, ALT and AST≤5×ULN, creatinine≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds
  • life expectancy of at least 6 months

Exclusion Criteria:

  • Macrovascular invasion or extrahepatic metastasis
  • Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy
  • Organ (heart and kidneys) dysfunction
  • History of other malignancies
  • Uncontrollable infection
  • History of organ or cells transplantation
  • History of HIV
  • Pregnant or lactating patients

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
Patients will receive SIRT treatment
Procedure: SIRT
The patients will receive 1-2 sessions of SIRT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR) per mRECIST
Time Frame: 3 years
The proportion of patients with the best response of complete response (CR) or partial response (PR) according to mRECIST
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR) per RECIST 1.1
Time Frame: 3 years
The proportion of patients with the best response of complete response (CR) or partial response (PR) according to RECIST 1.1
3 years
Disease control rate (DCR)
Time Frame: 3 years
The proportion of patients with the best response of CR, PR, or stable disease (SD) according to mRECIST and RECIST 1.1
3 years
Progression free survival (PFS)
Time Frame: 3 years
The time from date of treatment initiation until the first occurrence of disease progression (according to mRECIST and RECIST 1.1) or death due to any cause, whichever occurs first.
3 years
time to response (TTR)
Time Frame: 3 years
The time from treatment initiation to first tumour remission (mRECIST and RECIST 1.1)
3 years
Duration of response (DOR)
Time Frame: 3 years
Time from first tumor response to first disease progression (mRECIST and RECIST 1.1 assessment) or death from any cause (whichever occurs first)
3 years
Overall survival (OS)
Time Frame: 4 years
The time from date of treatment initiation to death due to any cause
4 years
Adverse Events (AEs)
Time Frame: 3 years
Number of patients with AEs assessed by Common Terminology Criteria for Adverse Events 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)

December 1, 2024

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2027

Study Registration Dates

First Submitted

November 24, 2024

First Submitted That Met QC Criteria

November 24, 2024

First Posted (Actual)

November 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 26, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIIR-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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