Clinical trial · Interventional
Lenvatinib, Sintilimab Plus SIRT for Unresectable HCC
Lenvatinib, Sintilimab Plus Y-90 Selective Internal Radiation Therapy for Patients With Unresectable Intermediate-advanced Hepatocellular Carcinoma: a Prospective, Single-center, Single Arm Trial
NCT05992584CI-TRIAL-00069611unknownPhase 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, sintilimab plus Y-90 selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC).
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 | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenvatinib, sintilimab plus SIRT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Len-Sin-SIRT
- description
- Lenvatinib, sintilimab plus SIRT
- interventionNames
- Drug: Lenvatinib, sintilimab plus SIRT
Primary outcomes (1)
- measure
- Progression free survival (PFS) according to mRECIST
- timeFrame
- 2.5 years
- description
- The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
Secondary outcomes (5)
- measure
- Progression free survival (PFS) according to RECIST 1.1
- timeFrame
- 2.5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Unresectable HCC (BCLC stage B/C) with diagnosis confirmed by histology/cytology or clinically * At least one measurable untreated lesion * Intrahepatic tumors can be treated with 1-2 session of SIRT * Child-Pugh score 5-7 * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 * Life expectancy of at least 3 months * Patients with active hepatitis B are allowed, but they need to receive antiviral treatment to achieve a HBV DNA\<10\^3 IU/mL * Patients with hepatitis C need to finish the anti-HCV treatment Exclusion Criteria: * tumor extent ≥70% liver occupation * Tumor thrombus involving main portal vein or both the first left and right branch of portal vein * Vena cava invasion * Central nervous system metastasis * Metastatic disease that involves major airways or blood vessels * Patients who previously received hepatic arterial infusion chemotherapy (HAIC), transarterial chemoembolization (TACE), transarterial embolization (TAE), radiotherapy, systemic therapy, or immunotherapy for HCC * History of organ and cell transplantation * Prior esophageal and/or gastric varices bleeding * History of hepatic encephalopathy * Peripheral blood white blood cell count\<3×10\^9/L, platelet count\<50×10\^9/L * Prolongation of prothrombin time ≥ 4 seconds * Severe organ dysfunction (heart, lungs, kidneys) * History of malignancy other than HCC * HBsAg and anti-HCV antibody positive concurrently * Human immunodeficiency virus (HIV) infected
References
Publications (0)
Data not yet available
No reference posted for this study.