Combining lenvatinib with iodine-125 seed brachytherapy for treating liver cancer
Official title: Lenvatinib Plus Iodine-125 Seed Brachytherapy Compared With Lenvatinib Alone for TACE-refractory Hepatocellular Carcinoma: a Single Center, Prospective, Randomized Control Trail
Run by Second Affiliated Hospital of Guangzhou Medical University · NCT05608213 · Data updated 2026-11-12
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 | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 187 (estimated) |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, lenvatinib |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | November 2, 2022 |
| Main results expected | October 31, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | November 8, 2022 |
| Trial ID | NCT05608213 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with confirmed HCC who have not responded to TACE and have measurable intrahepatic lesions.
✕Probably not a fit
Patients with extrahepatic metastasis or significant portal vein involvement are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While similar approaches have been explored, this specific combination of treatments is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Mingyue Cai, MD
- Email: cai020@yeah.net
- Phone: +86-20-34156205
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.