Second Affiliated Hospital of Guangzhou Medical University
Phase
Phase 2
Started
2024-12-01
Last updated
2025-01-28
Condition(s) studied
Hepatocellular Carcinoma Non-Resectable
Investigational drug(s) / intervention(s)
SIRT
SIRT: The patients will receive 1-2 sessions of SIRT.
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
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
Trial sites (2)
Facility
City
Region
Status
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou
Guangdong
Not Yet Recruiting
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou
Guangdong
Recruiting
More Second Affiliated Hospital of Guangzhou Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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