Combining Lenvatinib with SIRT for Advanced Liver Cancer

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

This study is testing whether combining a cancer drug called lenvatinib with a type of radiation therapy can help people with advanced liver cancer that hasn't improved with other treatments.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Guangzhou Medical University (other)
• Drugs / interventions: chemotherapy, lenvatinib
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06904196 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of combining lenvatinib with selective internal radiation therapy (SIRT) compared to lenvatinib alone in patients with hepatocellular carcinoma (HCC) that has not responded to transarterial chemoembolization (TACE). The study will enroll 78 patients, who will be assigned to either the combination treatment or lenvatinib alone. The primary goal is to measure the objective response rate, while secondary goals include assessing disease control rate, progression-free survival, and overall survival. Treatment will continue until disease progression or other specified criteria are met.

Who should consider this trial

Good fit: Ideal candidates include patients with pathologically confirmed HCC who have not responded to TACE and have measurable intrahepatic lesions.

Not a fit: Patients with extrahepatic metastasis or those with severe liver dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more effective treatment option for patients with TACE-refractory HCC.

How similar studies have performed: While this approach is innovative, similar studies combining targeted therapies with radiation have shown promise in other cancer types.

Eligibility criteria

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

Where this trial is running

Guangzhou, Guangdong

• The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Mingyue Cai, Dr.

Conditions: Hepatocellular Carcinoma Non-resectable, hepatocellular carcinoma, Lenvatinib, Yttrium-90