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Recruiting NCT06707233

Y-90 SIRT for Unresectable HCC Larger Than 7cm

Phase II Interventional Hepatocellular Carcinoma Non-Resectable

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SIRT.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma Non-Resectable. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Procedure SIRT
    The patients will receive 1-2 sessions of SIRT.

Primary outcome measures

  • Objective response rate (ORR) per mRECIST [Time frame: 3 years]
Secondary outcome measures (7)
  • Objective response rate (ORR) per RECIST 1.1 [Time frame: 3 years]
  • Disease control rate (DCR) [Time frame: 3 years]
  • Progression free survival (PFS) [Time frame: 3 years]
  • time to response (TTR) [Time frame: 3 years]
  • Duration of response (DOR) [Time frame: 3 years]
  • Overall survival (OS) [Time frame: 4 years]
  • Adverse Events (AEs) [Time frame: 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou
  • The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou

Identifiers

NCT: NCT06707233 · MIIR-17

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗