Y-90 SIRT for Unresectable HCC Larger Than 7cm

NCT ID: NCT06707233

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2027-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatocellular Carcinoma Non-Resectable

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SIRT

Patients will receive SIRT treatment

Group Type EXPERIMENTAL

SIRT

Intervention Type PROCEDURE

The patients will receive 1-2 sessions of SIRT.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SIRT

The patients will receive 1-2 sessions of SIRT.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mingyue Cai, Dr.

Role: CONTACT

+86-20-34156205

Kangshun Zhu, Dr.

Role: CONTACT

+86-20-34156205

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kangshun Zhu, Dr.

Role: primary

+86-20-34156205

Mingyue Cai, Dr.

Role: primary

+86-20-34156205

Kangshun Zhu, Dr.

Role: backup

+86-20-34156205

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MIIR-17

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.