A Trial of Systemic Chemotherapy in Combination With Conventional Transarterial Chemoembolization in Patients With Advanced Intra-Hepatic Cholangiocarcinoma

Stopped early · Phase 2

Conditions studied: Unresectable Intrahepatic Cholangiocarcinoma

In brief

The study will be a single-center, single-arm, Phase II study of gemcitabine and cisplatin in combination with conventional trans-arterial chemoembolization therapy in adult patients with advanced ICC. 25 patients will be enrolled over the course of 2 years, with an additional 1.5 years for patient follow-up.

Key facts

Study ID

NCT02994251

Run by

Yale University

People needed

1

Starts

2017-06-21

Expected to finish

2018-11-06

Last updated by the study team

2019-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is at least 18 years of age.
• Patient has advanced, unresectable intrahepatic cholangiocarcinoma (ICC). Advanced, unresectable ICC is defined as biopsy-confirmed adenocarcinoma in the liver, with an immunohistochemical profile consistent with a pancreatico-biliary primary, not involving the common bile duct or bifurcation, and not amenable to surgical resection.
• Eligible for conventional TACE as defined by local treatment guidelines.
• Child-Pugh class of A to B7.
• Adequate end-organ and bone marrow function as manifested as:
• Hemoglobin ≥ 9 g/dL
• Absolute neutrophil count ≥ 1500/mm3
• Creatinine ≤ 2.0 g/dL
• AST and ALT ≤ 5 x ULN
• Albumin ≥ 2.4 mg/dL
• Total bilirubin ≤ 2.5 mg/dL
• Platelets ≥ 100,000/mm3
• For TACE procedures, subjects are allowed to have platelets ≥ 75,000/mm3.
• Disease is liver-dominant with >70% of measurable disease burden within the hepatic parenchyma.
• No prior surgery or chemotherapy for ICC.
• ECOG performance status of 0-1.
• No other active malignancy within 2 years.
• Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of the study.
• Ability to understand and willingness to sign a written informed consent document.

You may not qualify if…

• Prior or concurrent chemotherapy treatment for advanced ICC.
• History of allergic reactions attributed to compounds of similar chemical or biological composition to gemcitabine, cisplatin, doxorubicin, or mitomycin-C.
• Active treatment with CYP3A4 strong inhibitors or inducers.
• Recent surgical procedure within 21 days of study enrollment.
• Severe and/or uncontrolled co-morbid medical conditions including, but not limited to, active infection, viral hepatitis, congestive heart failure, cardiac arrhythmia, unstable angina pectoris, and psychiatric illness or social circumstance that would limit compliance with study requirements.
• Pregnancy during study duration.
• Active immunosuppressive medications.
• Presence of grade 2 or higher hepatic encephalopathy.
• Complete occlusion of the entire portal venous system. Partial or branch portal vein occlusion allowed if without reversal of flow.
• Radiotherapy within 21 days from treatment with study interventions or medications.
• Current, recent (within 4 weeks of first infusion of this study), or planned participation in additional experimental drug.
• Unstable angina.
• New York Heart Association (NYHA) Grade II or greater congestive heart failure (Appendix C).
• History of myocardial infarction or CVA within 6 months prior to study enrollment.
• Clinically significant peripheral vascular disease.
• Inability to comply with study and/or follow-up procedures.
• Life expectancy of less than 12 weeks.

Where it is running

• Smilow Cancer Center — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.