Status:
RECRUITING
Lenvatinib, Sintilimab, and DEB-TACE With/Without HAIC for HCC >7 cm With PVTT
Lead Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Collaborating Sponsors:
Affiliated Hospital of Guangdong Medical University
Zhongshan People's Hospital, Guangdong, China
Conditions:
Hepatocellular Carcinoma Non-resectable
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 chemoth...
Detailed Description
This is a multicenter, prospective and randomized study to evaluate the efficacy and safety of LEN+SIN+DEB-TACE+HAIC compared with LEN+SIN+DEB-TACE for unresectable large HCC (\>7cm) with PVTT. 320 p...
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; prothrombin time prolongation ≤4 seconds
- life expectancy of at least 3 months
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2030
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT06904183
Start Date
April 1 2025
End Date
March 31 2030
Last Update
April 29 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510260