Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC

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 transarterial chemoembolization (TACE).

Eligibility

Inclusion Criteria:

* 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 Criteria:

* 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

Conditions4

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