Clinical trial · Interventional
Lenvatinib Plus I-125 Seed Brachytherapy vs. Lenvatinib for TACE-refractory HCC
Lenvatinib Plus Iodine-125 Seed Brachytherapy Compared With Lenvatinib Alone for TACE-refractory Hepatocellular Carcinoma: a Single Center, Prospective, Randomized Control Trail
NCT05608213CI-TRIAL-00062032recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is conducted to evaluate the efficacy and safety of lenvatinib plus iodine-125 seed brachytherapy (Len-I) compared with lenvatinib (Len) alone for patients with hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization (TACE).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma Non-resectable | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenvatinib | Drug | Lenvatinib | ALIAS |
| Lenvatinib Plus I-125 Seed Brachytherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Len-I
- interventionNames
- Procedure: Lenvatinib Plus I-125 Seed Brachytherapy
- type
- ACTIVE_COMPARATOR
- label
- Len
- interventionNames
- Drug: Lenvatinib
Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- 4 years
- description
- The time from date of randomization to death due to any cause.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.