Actively Recruiting
Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC
Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2025-04-29
78
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is conducted to evaluate the efficacy and safety of lenvatinib plus SIRT (LEN+SIRT) compared with lenvatinib (LEN) alone for patients with hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization (TACE).
CONDITIONS
Official Title
Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed or clinically diagnosed hepatocellular carcinoma (HCC)
- Diagnosis of HCC with TACE refractoriness as per Japan Society of Hepatology (2021) criteria
- Allowed if tumor recurred after surgical resection or ablation
- At least one measurable intrahepatic target lesion
- Child-Pugh class A or B liver function
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Tumor extent less than 70% of liver occupation
- Suitable for SIRT confirmed by evaluation including SPECT/CT after arterial perfusion with 99Tc-MAA
- Adequate organ and blood function: platelet count ≥50×10^9/L, leukocyte >3.0×10^9/L, neutrophil count ≥1.5×10^9/L, hemoglobin ≥85 g/L, ALT and AST ≤5× upper limit of normal, albumin ≥28 g/L, total bilirubin ≤3× upper limit of normal, creatinine ≤1.5× upper limit of normal, prothrombin time prolongation ≤4 seconds
- Life expectancy of at least 3 months
You will not qualify if you...
- Presence of cancer spread outside the liver (extrahepatic metastasis)
- Tumor thrombus involving main portal vein or both first left and right branches of portal vein
- Invasion of vena cava by tumor
- Previous treatment with hepatic arterial infusion chemotherapy, radiotherapy, or systemic therapy for HCC
- History of organ or cell transplantation
- History of esophageal or gastric variceal bleeding
- History of hepatic encephalopathy
- History of other cancers
- Infection with human immunodeficiency virus (HIV)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510260
Actively Recruiting
Research Team
M
Mingyue Cai, Dr.
CONTACT
M
Mingyue Cai, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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