Actively Recruiting
Lenvatinib Plus DEB-TACE and HAIC vs. Lenvatinib Plus DEB-TACE for Large HCC With PVTT
Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2025-01-29
178
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 plus transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (Len+DEB-TACE+HAIC) versus lenvatinib plus DEB-TACE (Len+DEB-TACE) for large hepatocellular carcinoma (\> 7cm) with portal vein tumor thrombosis (PVTT).
CONDITIONS
Official Title
Lenvatinib Plus DEB-TACE and HAIC vs. Lenvatinib Plus DEB-TACE for Large HCC With PVTT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of hepatocellular carcinoma (HCC)
- Largest tumor in the liver larger than 7 cm
- Presence of portal vein tumor thrombosis (PVTT) seen on imaging
- Tumor recurrence after curative treatment like hepatectomy or ablation is allowed
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Child-Pugh liver function class A or B
- Adequate blood counts and organ function including leukocytes >3.0 x 10^9/L, neutrophils >1.5 x 10^9/L, platelets ≥75 x 10^9/L, hemoglobin ≥85 g/L, liver enzymes ≤5 times upper normal limit, and creatinine clearance rate ≤1.5 times upper normal limit
- Life expectancy of at least 3 months
You will not qualify if you...
- Diffuse hepatocellular carcinoma
- Presence of tumor thrombus in the vena cava
- Involvement of the central nervous system
- Previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy
- Organ dysfunction (heart or kidneys) that prevents tolerance of TACE or HAIC
- History of other cancers
- Uncontrolled infections
- History of HIV infection
- History of organ or cell transplantation
- Prolonged prothrombin time greater than 4 seconds
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
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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