Lenvatinib Combined With Yttrium-90 Selective Internal Radiation Therapy (SIRT) Versus Lenvatinib Alone in TACE-Refractory Hepatocellular Carcinoma: A Prospective Non-Randomized Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Combination product, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
The Second Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Mingyue Cai, Dr.
cai020@yeah.net
+86-20-34156205
Backup
Mingyue Cai, Dr.
zhksh010@163.com
+86-20-34156205
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2029-03-31
Participants
Target number of participants: 78
Treatments
Experimental: Len+SIRT
Lenvatinib plus SIRT
Active_comparator: LEN
Lenvatinib alone
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital of Guangzhou Medical University

This content was sourced from clinicaltrials.gov

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