Actively Recruiting
Y-90 SIRT for Unresectable HCC Larger Than 7cm
Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2025-01-28
33
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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).
CONDITIONS
Official Title
Y-90 SIRT for Unresectable HCC Larger Than 7cm
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed or clinically diagnosed hepatocellular carcinoma (HCC)
- Unresectable HCC as assessed by a surgical team
- Largest tumor size greater than 7 cm
- Eligible if tumor recurrence after hepatectomy or ablation
- At least one measurable intrahepatic target lesion
- Suitable for SIRT treatment after evaluation including SPECT/CT
- Child-Pugh score of 7 or less
- ECOG performance status of 0 or 1
- Adequate organ and blood function with specified blood counts and liver enzyme levels
- Life expectancy of at least 6 months
You will not qualify if you...
- Macrovascular invasion or cancer spread outside the liver
- Decompensated liver function including ascites, bleeding varices, or encephalopathy
- Dysfunction of heart or kidneys
- History of other cancers
- Uncontrollable infection
- History of organ or cell transplantation
- History of HIV infection
- Pregnant or breastfeeding patients
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510260
Not Yet Recruiting
2
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510260
Actively Recruiting
Research Team
M
Mingyue Cai, Dr.
CONTACT
K
Kangshun Zhu, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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