Clinical trial · Interventional
TACE Plus Multikinase Inhibitor and I-125 Seeds Brachytherapy for HCC With Branch PVTT
Transarterial Chemoembolization Combined With Lenvatinib and Iodion-125 Seeds Brachytherapy for Hepatocellular Carcinoma With Portal Vein Branch Tumor Thrombus: a Single Center, Prospective, Randomized Control Trail
- 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 transarterial chemoembolization (TACE) combined with lenvatinib and iodion-125 seeds brachytherapy (TACE-Len-I) compared with TACE combined with lenvatinib (TACE-Len) for hepatocellular carcinoma (HCC) with portal vein branch tumor thrombus (branch PVTT).
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 |
|---|---|---|---|
| TACE combined with lenvatinib | Procedure | — | UNRESOLVED |
| TACE combined with lenvatinib and iodion-125 seeds brachytherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TACE-Len-I
- description
- TACE combined with lenvatinib and iodion-125 seeds brachytherapy
- interventionNames
- Procedure: TACE combined with lenvatinib and iodion-125 seeds brachytherapy
- type
- ACTIVE_COMPARATOR
- label
- TACE-Len
- description
- TACE combined with lenvatinib
- interventionNames
- Procedure: TACE combined with lenvatinib
Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- 2 years.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age between18 and 75 years. 2. HCC confirmed by histopathology and/or cytology, or diagnosed clinically. 3. Accompanied with tumor thrombus involving unilateral portal vein branch. 4. Child-Pugh class A or B. 5. Eastern Cooperative Group performance status (ECOG) score of 0-2. 6. Serum bilirubin ≤ 51.3 μmol/L, albumin ≥ 28g/L, ALT and AST ≤ 5 times of the upper normal limit, and creatinine ≤ 20g/L. 7. Prothrombin time prolonged for less than 4s or international normalized ratio \< 1.7. 8. Neutrophilic granulocyte count ≥ 1.5×10\^9/L, platelet count ≥ 50×10\^9/L, and hemoglobin level ≥ 85g/L; 9. At least one measurable intrahepatic target lesion. 10. Life expectancy of at least 3 months. Exclusion Criteria: 1. Diffuse HCC. 2. Extrahepatic metastasis. 3. Tumor thrombus involving both the left and right branch of portal vein or main portal vein. 4. Hepatic vein and/or vena cava invasion. 5. History of organ or cells transplantation. 6. Previous treatment with TACE, intra-arterial infusion chemotherapy, radiotherapy or systemic therapy. 7. History of other malignancies. 8. Serious medical comorbidities. 9. Female patients who are pregnancy or breastfeeding.
References
Publications (0)
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