Actively Recruiting
Lenvatinib Plus I-125 Seed Brachytherapy vs. Lenvatinib for TACE-refractory HCC
Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2022-11-08
187
Participants Needed
1
Research Sites
212 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 iodine-125 seed brachytherapy (Len-I) compared with lenvatinib (Len) alone for patients with hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization (TACE).
CONDITIONS
Official Title
Lenvatinib Plus I-125 Seed Brachytherapy vs. Lenvatinib for TACE-refractory HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- HCC confirmed by histopathology, cytology, or clinical diagnosis
- Diagnosis of TACE-refractory HCC by Japan Society of Hepatology (2021) criteria
- Tumor recurrence after surgery or ablation allowed
- At least one measurable intrahepatic tumor lesion
- Child-Pugh liver function class A or B
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
You will not qualify if you...
- Presence of cancer spread outside the liver (extrahepatic metastasis)
- Tumor thrombus in main portal vein or both first left and right portal vein branches
- Invasion of the vena cava
- Prior treatment with systemic therapy, immunotherapy, hepatic arterial infusion chemotherapy, or radiotherapy for HCC
- History of organ or cell transplantation
- History of bleeding from esophagogastric varices
- History of hepatic encephalopathy
- Platelet count below 50 x 10^9/L
- Prolonged prothrombin time of 4 seconds or more
- Severe heart, lung, or kidney dysfunction
- History of other cancers besides HCC
AI-Screening
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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, MD
CONTACT
K
Kangshun Zhu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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