Y-90 SIRT for Unresectable HCC Larger Than 7cm

Phase 2

Recruiting

• Conditions: Hepatocellular Carcinoma Non-Resectable

• Registration Number: NCT06707233
• Lead Sponsor: Second Affiliated Hospital of Guangzhou Medical University

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2024-11-24
• Study First Submitted QC: 2024-11-24
• Study First Posted: 2024-11-27
• Study Start: 2024-12-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-26
• Last Update Posted: 2025-01-28
• Primary Completion: 2026-11-30
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR) per mRECIST	3 years	The proportion of patients with the best response of complete response (CR) or partial response (PR) according to mRECIST

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR) per RECIST 1.1	3 years	The proportion of patients with the best response of complete response (CR) or partial response (PR) according to RECIST 1.1
Disease control rate (DCR)	3 years	The proportion of patients with the best response of CR, PR, or stable disease (SD) according to mRECIST and RECIST 1.1
Progression free survival (PFS)	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.
time to response (TTR)	3 years	The time from treatment initiation to first tumour remission (mRECIST and RECIST 1.1)
Duration of response (DOR)	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)
Overall survival (OS)	4 years	The time from date of treatment initiation to death due to any cause
Adverse Events (AEs)	3 years	Number of patients with AEs assessed by Common Terminology Criteria for Adverse Events v5.0

Trial Locations

Locations (1)

The Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China