Combining lenvatinib with iodine-125 seed brachytherapy for treating liver cancer

Lenvatinib Plus Iodine-125 Seed Brachytherapy Compared With Lenvatinib Alone for TACE-refractory Hepatocellular Carcinoma: a Single Center, Prospective, Randomized Control Trail

This study is testing if combining a medication called lenvatinib with a special type of radiation therapy can help people with liver cancer that hasn't improved with other treatments live longer and feel better.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 187 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Guangzhou Medical University (other)
• Drugs / interventions: chemotherapy, immunotherapy, lenvatinib
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05608213 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of combining lenvatinib with iodine-125 seed brachytherapy compared to lenvatinib alone in patients with hepatocellular carcinoma (HCC) that has not responded to transarterial chemoembolization (TACE). It is a single-center, prospective, randomized controlled trial involving 187 patients who will be assigned to either treatment group. The primary goal is to assess overall survival, while secondary goals include progression-free survival, time to progression, and response rates. Patients will receive treatment until disease progression or intolerable side effects occur.

Who should consider this trial

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

Not a fit: Patients with extrahepatic metastasis or significant portal vein involvement are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve survival rates and treatment outcomes for patients with TACE-refractory HCC.

How similar studies have performed: While similar approaches have been explored, this specific combination of treatments is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* HCC confirmed by histopathology and/or cytology, or diagnosed clinically
* 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
* Life expectancy of at least 3 months

Exclusion Criteria:

* Extrahepatic metastasis
* Tumor thrombus involving main portal vein or both the first left and right branch of portal vein
* Vena cava invasion
* Patients who received prior systemic therapy, immunotherapy, hepatic arterial infusion chemotherapy (HAIC) or radiotherapy for HCC
* History of organ and cell transplantation
* History of bleeding from esophagogastric varices
* History of hepatic encephalopathy
* Hematologic examination: platelets \<50×10\^9/L
* Prothrombin time prolongation ≥ 4s
* Severe organ (heart, lung, kidney) dysfunction
* History of malignancy other than HCC

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, MD

Conditions: Hepatocellular Carcinoma Non-resectable, Hepatocellular Carcinoma, Lenvatinib, iodion-125 seed