Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC
Recruiting now · Phase 2
Conditions studied: Hepatocellular Carcinoma Non-resectable
In brief
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 transarterial chemoembolization (TACE).
Key facts
- Study ID
- NCT06904196
- Run by
- Second Affiliated Hospital of Guangzhou Medical University
- People needed
- 78
- Starts
- 2025-04-01
- Expected to finish
- 2029-03-31
- Last updated by the study team
- 2025-04-29
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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