Actively Recruiting
Lenvatinib, Sintilimab, and DEB-TACE With/Without HAIC for HCC >7 cm With PVTT
Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2025-04-29
320
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital of Guangzhou Medical University
Lead Sponsor
A
Affiliated Hospital of Guangdong Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is conducted to evaluate the efficacy and safety of lenvatinib plus sintilimab, transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (LEN+SIN+DEB-TACE+HAIC) versus lenvatinib plus sintilimab and DEB-TACE (LEN+SIN+DEB-TACE) for large hepatocellular carcinoma (\> 7cm) with portal vein tumor thrombosis (PVTT).
CONDITIONS
Official Title
Lenvatinib, Sintilimab, and DEB-TACE With/Without HAIC for HCC >7 cm With PVTT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of hepatocellular carcinoma
- Largest intrahepatic lesion larger than 7 cm
- Presence of portal vein tumor thrombosis confirmed by imaging
- Eligible if tumor recurred after curative treatment such as hepatectomy or ablation
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Child-Pugh class A or B liver function
- Adequate blood counts and organ function (leukocytes >3.0 x 10^9/L, neutrophils >1.5 x 10^9/L, platelets 275 x 10^9/L, hemoglobin 285 g/L)
- Liver enzymes (ALT and AST) no more than 5 times the upper normal limit
- Creatinine clearance rate no more than 1.5 times the upper normal limit
- Prothrombin time prolongation less than or equal to 4 seconds
- Life expectancy of at least 3 months
You will not qualify if you...
- Presence of vena cava tumor thrombus
- Involvement of the central nervous system
- Previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy
- Organ dysfunction of the heart or kidneys preventing tolerance of TACE or HAIC
- History of other malignancies
- Uncontrolled infection
- History of HIV infection
- History of organ or cell transplantation
AI-Screening
AI-Powered 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, Dr.
CONTACT
K
Kangshun Zhu, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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