Status:
RECRUITING
Lenvatinib, Sintilimab Plus SIRT for Unresectable HCC
Lead Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study is conducted to evaluate the efficacy and safety of lenvatinib, sintilimab plus Y-90 selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatoc...
Detailed Description
This is a single-center, prospective study to evaluate the efficacy and safety of lenvatinib, sintilimab plus SIRT (Len-Sin-SIRT) in patient with unresectable HCC. 30 patients with unresectable inter...
Eligibility Criteria
Inclusion
- Unresectable HCC (BCLC stage B/C) with diagnosis confirmed by histology/cytology or clinically
- At least one measurable untreated lesion
- Intrahepatic tumors can be treated with 1-2 session of SIRT
- Child-Pugh score 5-7
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- Life expectancy of at least 3 months
- Patients with active hepatitis B are allowed, but they need to receive antiviral treatment to achieve a HBV DNA\<10\^3 IU/mL
- Patients with hepatitis C need to finish the anti-HCV treatment
Exclusion
- tumor extent ≥70% liver occupation
- Tumor thrombus involving main portal vein or both the first left and right branch of portal vein
- Vena cava invasion
- Central nervous system metastasis
- Metastatic disease that involves major airways or blood vessels
- Patients who previously received hepatic arterial infusion chemotherapy (HAIC), transarterial chemoembolization (TACE), transarterial embolization (TAE), radiotherapy, systemic therapy, or immunotherapy for HCC
- History of organ and cell transplantation
- Prior esophageal and/or gastric varices bleeding
- History of hepatic encephalopathy
- Peripheral blood white blood cell count\<3×10\^9/L, platelet count\<50×10\^9/L
- Prolongation of prothrombin time ≥ 4 seconds
- Severe organ dysfunction (heart, lungs, kidneys)
- History of malignancy other than HCC
- HBsAg and anti-HCV antibody positive concurrently
- Human immunodeficiency virus (HIV) infected
Key Trial Info
Start Date :
August 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 9 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05992584
Start Date
August 10 2023
End Date
August 9 2026
Last Update
September 14 2023
Active Locations (1)
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1
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510260