Clinical trial · Interventional
Y-90 SIRT for Unresectable HCC Larger Than 7cm
Y-90 Selective Internal Radiation Therapy for Unresectable Hepatocellular Carcinoma Larger Than 7cm: a Prospective, Single Arm Trial
- 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 is a phase II clinical study to evaluate the efficacy and safety of SIRT in patients with HCC greater than 7 cm. After enrollment, patients received yttrium-90 selective internal radiation therapy. The primary endpoint of the study is objective reponse rate (ORR) as assessed by mRECIST. Secondary endpoints were: objective response rate (ORR) as assessed by RECIST 1.1, disease control rate (DCR), progression-free survival (PFS), time to response (TTR), duration of response (DOR), overall survival (OS), and safety (incidence and severity of adverse events).
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SIRT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SIRT
- description
- Patients will receive SIRT treatment
- interventionNames
- Procedure: SIRT
Primary outcomes (1)
- measure
- Objective response rate (ORR) per mRECIST
- timeFrame
- 3 years
- description
- The proportion of patients with the best response of complete response (CR) or partial response (PR) according to mRECIST
Secondary outcomes (7)
- measure
- Objective response rate (ORR) per RECIST 1.1
- timeFrame
- 3 years
- description
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 * Unresectable HCC as assessed by a team of surgeons * The largest tumor size \> 7 cm * Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment * At least one measurable intrahepatic target lesion * Appropriate for SIRT treatment after evaluation (including SPECT/CT evaluation after arterial perfusion with 99Tc-MAA) * Child-Pugh score ≤ 7 * ECOG PS ≤ 1 * Adequate organ and hematologic function with platelet count ≥75×10\^9/L, leukocyte \>3.0×10\^9/L, Neutrophil count ≥1.5×10\^9/L, haemoglobin ≥85 g/L, ALT and AST≤5×ULN, creatinine≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds * life expectancy of at least 6 months Exclusion Criteria: * Macrovascular invasion or extrahepatic metastasis * Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy * Organ (heart and kidneys) dysfunction * History of other malignancies * Uncontrollable infection * History of organ or cells transplantation * History of HIV * Pregnant or lactating patients
References
Publications (0)
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