Y-90 SIRT for Unresectable HCC Larger Than 7cm
Y-90 Selective Internal Radiation Therapy for Unresectable Hepatocellular Carcinoma Larger Than 7cm: a Prospective, Single Arm Trial
Second Affiliated Hospital of Guangzhou Medical University
33 participants
Dec 1, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria10
- 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 Criteria8
- 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
Interventions
The patients will receive 1-2 sessions of SIRT.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06707233