Clinical trial · Interventional
Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin
Phase I Trial of Gemcitabine With TheraSphere® (Yttrium-90) in Patients With Hepatic Tumors of Pancreatobiliary Origin
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI moved to different institution
Summary
Brief summary (as posted)
Therasphere is a form of treatment that has been designed to selectively deliver radiation to the cancer within the patient's liver. This form of treatment has been used in a number of clinical trials and has been approved for use in the treatment of liver cancer. The investigators want to test the safety of using Gemcitabine (a chemotherapy drug) with TheraSphere (radioactive beads that are injected directly into the blood vessel supplying the tumor in the liver) in patients with advanced pancreatobiliary tumors such as pancreatic cancer or cholangiocarcinoma (bile duct tumors) involving the liver.
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 |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine with TheraSphere | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine with TheraSphere
- interventionNames
- Drug: Gemcitabine with TheraSphere
Primary outcomes (1)
- measure
- The maximum tolerated dose of gemcitabine when given in combination with therasphere
- timeFrame
- 28 days
- description
- Patients will receive full dose therasphere. The gemcitabine dose will start out low and the dose will increase after first 3 patients if no significant side effects are observed. The investigators will continue to increase the dose of gemcitabine as long as the investigators do not observe side effects or until we reach full dose of gemcitabine.
Secondary outcomes (3)
- measure
- Toxicities (side effects) experienced by patients on the trial
- timeFrame
- 90 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologic or cytologic diagnosis of pancreatic cancer or cholangiocarcinoma 2. Liver predominant disease defined as \- Cholangiocarcinoma: liver disease should be unresectable \- Limited extra hepatic metastasis defined as: i. Lung metastasis: 6 or less nodules with no nodule greater than 1.5 cm. ii. Abdominal lymph nodes iii. Pancreatic primary as long as the size is less than 4 cm in size iv. Bone metastasis 3. No prior systemic therapy for advanced stage disease 4. Measurable target tumors using standard imaging techniques 5. Lung shunting less than 20% 6. ECOG performance status 0-1 (See Appendix ) 7. Age ≥ 18 years 8. No other investigational agents while on protocol 9. Signed informed consent Exclusion Criteria: 1. Inadequate hepatic function: AST/ALT \> five times upper limit of normal, Bilirubin \>2.0 mg/dl or history of hepatic encephalopathy 2. Inadequate renal function Creatinine \> 2.0 mg/dL 3. Inadequate bone marrow function: platelets \< 100,000/mL or absolute neutrophil count \<1500/mL 4. Contraindication to angiography 5. Prior external beam radiotherapy to the upper abdomen 6. Clinical evidence of peritoneal metastasis or ascites 7. Patients with extensive tumor replacement in the liver defined as \>50% of liver involved with tumor 8. Any serious ongoing extra-hepatic disease such as infections.
References
Publications (0)
Data not yet available