Clinical trial · Interventional
Internal Radiation Therapy in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery
Clinical Trial of Sir Spheres® in Patients With Primary Hepatocellular Carcinoma
NCT00469963CI-TRIAL-00007935terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual
Summary
Brief summary (as posted)
RATIONALE: Specialized internal radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This clinical trial is studying how well internal radiation therapy works in treating patients with primary liver cancer that cannot be removed by surgery.
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 |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| yttrium Y 90 resin microspheres | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SIR-SPHERES
- interventionNames
- Procedure: quality-of-life assessment
- Radiation: yttrium Y 90 resin microspheres
Primary outcomes (1)
- measure
- Tumor response
- timeFrame
- up to 12 months
- description
- All uni-dimensional measurable lesions (longest diameter \>20mm with conventional techniques and \>10mm with spiral CT scans) up to a maximum of five lesions per organ with a maximum of 10 lesions in total are used to determine response.
Secondary outcomes (3)
- measure
- Toxicity
- timeFrame
- up to 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria:
* Diagnosis of hepatocellular carcinoma
* Not amenable to surgical resection or immediate liver transplantation
* Destaging of tumor prior to surgical resection or transplantation allowed
* Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) ≥ 10 mm by contrasted CT scan
* No equivocal, nonmeasurable, or nonevaluable liver cancer
* No more than 75% replacement of normal liver by tumor
* Cancer of the Liver Italian Program (CLIP) stage 1-3 disease
* No extra-hepatic metastases as determined by CT scan or MRI
Exclusion Criteria:
* Life expectancy ≥ 3 months
* Karnofsky performance status 50-100%
* Creatinine ≤ 1.5 mg/dL
* Bilirubin ≤ 2.0 mg/dL
* Albumin ≥ 3 g/dL
* Granulocyte count ≥ 1,500/mm³
* Platelet count ≥ 65,000/mm³
* INR ≤ 1.4
* Hemoglobin \> 9 g/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
* No nonmalignant disease that would render the patient ineligible for treatment according to this protocol
* No hepatic arterial anatomy that would prevent the administration of study drug into the liver
* Less than 20% arteriovenous lung shunting on a technetium 99m-labeled macroaggregated albumin nuclear scan
* No other malignancy within the past 5 years except for cured basal cell carcinoma of the skin or cured carcinoma in situ of the uterine cervix
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 90 days since prior surgery, chemotherapy, or locally ablative technique for the liver cancer
* More than 4 weeks since prior and no other concurrent investigational drug or agent/procedure (i.e., participation in another trial)
* No prior radiotherapy to the upper abdomen that included the liver in the treatment field
* No capecitabine within 8 weeks before or after study treatment
* No other anticancer treatment (except surgical resection) for liver cancer during and for 3 months after completion of study treatmentReferences
Publications (0)
Data not yet available
No reference posted for this study.