Clinical trial · Interventional
Study Of Intrahepatic Arterial Injection of 90-Y Glass Microspheres for Cholangiocarcinoma
Phase II Study Of Intrahepatic Arterial Injection of 90-Y Glass Microspheres As First-Line Treatment For Cholangiocarcinoma
NCT01253148CI-TRIAL-00026575completedN/AResults postedClinicalTrials.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)
The purpose of this study is to see if Therasphere will be a better way to treat cholangiocarcinoma. The investigators want to find out what effects, good and/or bad, this treatment will have on the patient and their cancer.
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 |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TheraSphere® Yttrium-90 (Y-90) Microspheres | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arterial Injection of 90-Y Microspheres
- description
- Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma
- interventionNames
- Device: TheraSphere® Yttrium-90 (Y-90) Microspheres
Primary outcomes (1)
- measure
- Median Progression Free Survival (PFS)
- timeFrame
- End of post treatment follow-up period of 20 months
- description
- PFS is defined as the duration of time from enrollment to time of progression or death from any cause. Progression will be defined as progressive disease in the treated lobe. If progression is seen in a treated lobe, this will be considered a treatment failure. Progressive Disease (PD) according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) Version 1.1.: At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have newly diagnosed or recurrent (post surgery) histologically or cytologically proven cholangiocarcinoma. * Patients can have solitary, multifocal unilobar, or bilobar disease without evidence of extrahepatic involvement. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>10 mm with spiral computed tomography (CT) scan or magnetic resonance imaging (MRI). * Age \>18 years * Life expectancy of greater than 3 months based on physician judgment * Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 (Karnofsky 50%) * No prior chemotherapy or radiation treatment for cholangiocarcinoma * Childs-Pugh score A or Childs-Pugh score B without portal vein thrombus * Lung shunting that predicts lung dose to be \<30 Gy in a single treatment * The effects of TheraSpheres on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because radioactive spheres are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Ability to understand and the willingness to sign a written informed consent document * Adequate baseline hematopoietic function: * total white blood cell count equal to or greater than 3,000/mm³ * absolute granulocyte count greater than 1,500/mm³ * platelet count equal to or greater than 100,000/mm³ * Hemoglobin \>8.0 Exclusion Criteria: * Patients receiving any other investigational agents * Patients with extrahepatic disease * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study because TheraSpheres are radioactive and radiation is a known agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with TheraSpheres, breastfeeding should be discontinued if the mother is treated with TheraSpheres. * Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. In addition, antiretrovirals are known radiation sensitizers and could dramatically increase the risk of fulminant hepatic failure. Therefore, HIV-positive patients are excluded from the study because of possible lethal side effects. * Bulk disease (tumor volume \> 70% of the target liver volume, or tumor nodules too numerous to count) * Aspartic transaminase (AST) or alanine transaminase (ALT) \> 5 times upper limit of normal (ULN) * Bilirubin \> 2 mg/dL * Child-Pugh C Liver Cirrhosis * Tumor volume \> 50% combined with an albumin \< 3 g/dL * Complete occlusion of main portal vein causing portal hypertension
References
Publications (0)
Data not yet available
No reference posted for this study.