Status:
RECRUITING
Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC
Lead Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
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 SIRT (LEN+SIRT) compared with lenvatinib (LEN) alone for patients with hepatocellular carcinoma (HCC) refractory to trans...
Detailed Description
This is a prospective, non-randomized controlled trial to evaluate the efficacy and safety of LEN+SIRT versus LEN alone for patients with TACE-refractory HCC. 78 patients (39 in each arm) with TACE-r...
Eligibility Criteria
Inclusion
- Pathologically confirmed or clinically diagnosed HCC
- Diagnosis of HCC with TACE refractoriness according to the criteria proposed by Japan Society of Hepatology (2021)
- Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included
- At least one measurable intrahepatic target lesion
- Child-Pugh class A/B
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Tumor extent \<70% liver occupation
- Candidates for SIRT must be confirmed suitable for SIRT after evaluation (including SPECT/CT evaluation after arterial perfusion with 99Tc-MAA)
- Adequate organ and hematologic function with platelet count ≥50×10\^9/L, leukocyte \>3.0×10\^9/L, Neutrophil count ≥1.5×10\^9/L, haemoglobin ≥85 g/L, ALT and AST≤5×ULN, albumin ≥28 g/L, total bilirubin ≤3× ULN, creatinine≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds
- Life expectancy of at least 3 months
Exclusion
- Extrahepatic metastasis
- Tumor thrombus involving main portal vein or both the first left and right branches of portal vein
- Vena cava invasion
- Patients who received prior hepatic arterial infusion chemotherapy (HAIC), radiotherapy, or systemic therapy, for HCC
- History of organ and cell transplantation
- History of esophageal or gastric variceal bleeding
- History of hepatic encephalopathy
- History of other malignancies
- Human immunodeficiency virus infection
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2029
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06904196
Start Date
April 1 2025
End Date
March 31 2029
Last Update
April 29 2025
Active Locations (1)
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1
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510260