Clinical trial · Interventional
SIRT for Potentially Resectable HCC
Y-90 Selective Internal Radiation Therapy for Potentially Resectable Hepatocellular Carcinoma: a Prospective, Single Arm Trial
NCT05994859CI-TRIAL-00069614recruitingN/AClinicalTrials.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 Y-90 selective internal radiation therapy (SIRT) in patients with potentially resectable 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 |
|---|---|---|---|
| SIRT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SIRT
- description
- Treatment with SIRT.
- interventionNames
- Procedure: SIRT
Primary outcomes (1)
- measure
- Success rate of conversion to resection
- timeFrame
- 3 years
- description
- The proportion of patients with initially unresectable HCC who were evaluated by the surgical team as suitable for second-stage surgical resection after SIRT
Secondary outcomes (7)
- measure
- Objective response rate (ORR)
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * HCC with diagnosis confirmed pathologically or clinically * No pervious treatment for HCC * At least one measurable intrahepatic target lesion * Potentially resectable HCC: tumor(s) confined to the left/right hemiliver, with/without invasion to the unilateral branch of the portal vein and/or hepatic vein * Disease amenable to SIRT (after evaluation) * Child-Pugh Class A or without cirrhosis * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 * 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 * Adequate organ and bone marrow function; the blood biochemical examination: platelet count ≥75×10\^9/L, white blood cell count \>3.0×10\^9/L, absolute value of neutrophils \>1.5×10\^9/L, hemoglobin ≥85 g/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR\<1.5 or PT/APTT normal range * Life expectancy of at least 6 months Exclusion Criteria: * Tumor involving main portal vein, bilateral branches of portal vein, or vena cava * tumor extention beyond one lobe of the liver * Bilobar tumor distribution * Extrahepatic metastasis * Decompensated liver function, including ascites, bleeding from esophageal and gastric varices, and/or hepatic encephalopathy * Organ (heart, kidney) dysfunction * HBsAg and anti-HCV antibody positive concurrently * History of malignancy other than HCC * Uncontrolled infection * History of HIV * History of organ and cell transplantation * Patients with bleeding tendency
References
Publications (0)
Data not yet available
No reference posted for this study.