Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT01434459
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01434459
Study Brief:
Protocol Section:
NCT01434459