RecruitingHepatocellular Carcinoma Non-resectable
Lenvatinib Plus DEB-TACE and HAIC vs. Lenvatinib Plus DEB-TACE for Large HCC With PVTT
Eligible age
18–75 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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).
Sponsor: Second Affiliated Hospital of Guangzhou Medical University
You may qualify if…
- ✓ a confirmed diagnosis of HCC
- ✓ the largest intrahepatic lesion \>7 cm
- ✓ presence of PVTT on imaging
- ✓ tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment
- ✓ Eastern Cooperative Oncology Group performance status ≤1
- ✓ Child-Pugh class A/B
- ✓ adequate hematologic and organ function, with leukocyte count\>3.0×10\^9/L, neutrophil count\>1.5×10\^9/L, platelet count≥75×10\^9/L, hemoglobin 85 g/L, alanine transaminase and aspartate transaminase≤5×upper limit of the normal, creatinine clearance rate≤1.5×upper limit of the normal
- ✓ life expectancy of at least 3 months
You may not qualify if…
- ✕ Diffuse HCC
- ✕ accompanied with vena cava tumor thrombus
- ✕ central nervous system involvement
- ✕ previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy
- ✕ organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment
- ✕ history of other malignancies
- ✕ uncontrollable infection
- ✕ history of HIV
Source: ClinicalTrials.gov · NCT06492395 · last updated 2025-01-29