Status:
RECRUITING
Lenvatinib Plus DEB-TACE and HAIC vs. Lenvatinib Plus DEB-TACE for Large HCC With PVTT
Lead Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Conditions:
Hepatocellular Carcinoma Non-resectable
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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)...
Detailed Description
This is a multicenter, prospective and randomized study to evaluate the efficacy and safety of Len+DEB-TACE+HAIC compared with Len+DEB-TACE for unresectable large HCC (\>7cm) with PVTT. 178 patients ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- history of organ or cells transplantation
- prothrombin time prolongation \>4 s
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT06492395
Start Date
August 1 2024
End Date
July 31 2027
Last Update
January 29 2025
Active Locations (1)
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1
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510260