Clinical trial · Interventional
Yttrium Y 90 Glass Microspheres and Capecitabine in Treating Patients With Liver Cholangiocarcinoma or Liver Metastases
Dose Escalating Study of Yttrium 90 Microspheres (TheraSphere) With Capecitabine (Xeloda) for Intrahepatic Cholangiocarcinoma or Metastatic Disease to the Liver
- 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)
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy, such as yttrium Y 90 glass microspheres that deliver a high dose of radiation directly to the tumor, may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Capecitabine may also make tumor cells more sensitive to radiation therapy. PURPOSE: This phase I trial is studying the side effects and best dose of yttrium Y 90 glass microspheres when given together with capecitabine in treating patients with liver cholangiocarcinoma or liver metastases.
Conditions
Conditions (2)
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 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| yttrium Y 90 glass microspheres | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort 1 (capecitabine, Y90)
- description
- 2,000mg/m2 capecitabine +110 Y90
- interventionNames
- Drug: capecitabine
- Radiation: yttrium Y 90 glass microspheres
- type
- EXPERIMENTAL
- label
- Cohort 2 (capecitabine , Y90)
- description
- 2,000mg/m2 capecitabine + 130 Y90
- interventionNames
- Drug: capecitabine
- Radiation: yttrium Y 90 glass microspheres
- type
- EXPERIMENTAL
- label
- Cohort 3 (capecitabine, Y90)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of 1 of the following: * Intrahepatic cholangiocarcinoma * Metastatic cancer confined to the liver * Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan * Must have tumor volume ≤ 50% of total liver volume based on visual estimation PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * ANC ≥ 1,500/mm\^3 * Platelet count ≥ 75,000/mm\^3 * Serum creatinine ≤ 2.0 mg/dL * Serum bilirubin ≤ 1.5 times upper limit of normal * Albumin ≥ 2.0 g/dL * No baseline symptoms or laboratory values \> grade 2 in severity by NCI CTCAE v 3.0 criteria * Not pregnant or nursing * Fertile patients must use effective contraception * No malabsorption syndrome * No severe liver dysfunction or pulmonary insufficiency * No complete occlusion of the main portal vein * No contraindication to iodine-based contrast agents * No contraindication to hepatic artery catheterization (e.g., vascular abnormalities or bleeding diathesis) * No prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to fluorouracil, or known dihydropyrimidine dehydrogenase deficiency PRIOR CONCURRENT THERAPY: * No prior radiotherapy to the liver * No more than 2 prior therapies for metastatic disease to the liver * No prior intervention to or compromise of the Ampulla of Vater * At least 4 weeks since prior and no concurrent sorivudine or brivudine * No concurrent cimetidine
References
Publications (0)
Data not yet available