Actively Recruiting
Lenvatinib+Sintilimab+TACE vs. Lenvatinib+TACE for Advanced HCC
Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2023-05-31
427
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, sintilimab plus TACE (Len-Sin-TACE) compared with lenvatinib plus TACE (Len-TACE) for patients with advanced hepatocellular carcinoma (HCC).
CONDITIONS
Official Title
Lenvatinib+Sintilimab+TACE vs. Lenvatinib+TACE for Advanced HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with advanced hepatocellular carcinoma (BCLC stage C or CNLC IIIa and IIIb) confirmed by histology, cytology, or clinical diagnosis
- Tumor recurrence after surgery or ablation is allowed
- At least one measurable tumor inside the liver
- Child-Pugh liver function class A or B
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected to live at least 3 months
You will not qualify if you...
- Obstructive portal vein tumor thrombus affecting both left and right portal veins or main portal vein without collateral vessels
- Tumor invasion of the inferior vena cava
- Metastasis to the central nervous system
- Prior systemic therapy, immunotherapy, TACE, TARE, TAE, hepatic arterial infusion chemotherapy, or radiation for HCC
- History of organ or cell transplantation
- History of bleeding from esophageal or gastric varices
- History of hepatic encephalopathy
- White blood cell count below 3.0 x 10^9/L or platelets below 50 x 10^9/L
- Prolonged prothrombin time by 4 seconds or more
- Severe dysfunction of heart, lung, or kidney
- History of cancers other than HCC
- Active hepatitis B or C infection with viral load above specified thresholds (HBV DNA > 1000 copies/ml, HCV RNA > 1000 copies/ml), unless controlled by antiviral treatment
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, 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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