Clinical trial · Interventional
Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC
Lenvatinib Combined With Yttrium-90 Selective Internal Radiation Therapy (SIRT) Versus Lenvatinib Alone in TACE-Refractory Hepatocellular Carcinoma: A Prospective Non-Randomized Controlled Study
NCT06904196CI-TRIAL-00089068recruitingPhase 2ClinicalTrials.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 SIRT (LEN+SIRT) 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 SIRT | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Len+SIRT
- description
- Lenvatinib plus SIRT
- interventionNames
- Combination Product: Lenvatinib plus SIRT
- type
- ACTIVE_COMPARATOR
- label
- LEN
- description
- Lenvatinib alone
- interventionNames
- Drug: Lenvatinib
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- 3 years
- description
- The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR) according to mRECIST
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.