Y-90 SIRT for Unresectable HCC Larger Than 7cm

Second Affiliated Hospital of Guangzhou Medical University

Status and phase: Enrolling; Phase 2

Conditions: Hepatocellular Carcinoma Non-Resectable

Treatments: Procedure: SIRT

Study type: Interventional

Funder types: Other

Identifiers

NCT06707233

MIIR-17

Details and patient eligibility

About

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).

Enrollment: 33 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

SIRT

Experimental group

Description:

Patients will receive SIRT treatment

Treatment:

Procedure: SIRT