Actively Recruiting
Lenvatinib, Sintilimab Plus SIRT for Unresectable HCC
Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2023-09-14
30
Participants Needed
1
Research Sites
156 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, sintilimab plus Y-90 selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC).
CONDITIONS
Official Title
Lenvatinib, Sintilimab Plus SIRT for Unresectable HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unresectable hepatocellular carcinoma (BCLC stage B or C) confirmed by histology, cytology, or clinical diagnosis
- At least one measurable untreated lesion
- Intrahepatic tumors treatable with 1-2 sessions of selective internal radiation therapy (SIRT)
- Child-Pugh liver function score between 5 and 7
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- For active hepatitis B, patients must be receiving antiviral treatment with HBV DNA under 10^3 IU/mL
- Patients with hepatitis C must have completed anti-HCV treatment
You will not qualify if you...
- Tumor occupying 70% or more of the liver
- Tumor thrombus in main portal vein or both first left and right branches of portal vein
- Invasion of the vena cava
- Metastasis to the central nervous system
- Metastatic disease involving major airways or blood vessels
- Previous hepatic arterial infusion chemotherapy (HAIC), transarterial chemoembolization (TACE), transarterial embolization (TAE), radiotherapy, systemic therapy, or immunotherapy for HCC
- History of organ or cell transplantation
- Prior bleeding from esophageal or gastric varices
- History of hepatic encephalopathy
- Low white blood cell count (<3 x 10^9/L) or platelet count (<50 x 10^9/L)
- Prolonged prothrombin time by 4 seconds or more
- Severe heart, lung, or kidney dysfunction
- History of cancers other than HCC
- Positive for both hepatitis B surface antigen and hepatitis C antibody
- 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
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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