Neoplasms

All Conditions

Rare Diseases

Cholangiocarcinoma

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

Intrahepatic Cholangiocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Irinotecan

Carboplatin

Gemcitabine

Cisplatin

Transarterial Chemoembolization (LC or ONCOZENE Bead) with Gem-Cis or Gem-Carbo

LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo

Gem-Cis or Gem-Carbo

Robert Martin, MD, PhD

The purpose of this study is to find out if the combination of trans-arterial chemoembolization (LC or ONCOZENE BEAD) plus infusional chemotherapy is safe and more effective than just receiving the infusional chemotherapy alone.

Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin

Comparative, Prospective, Open-labeled, Randomized Phase II Study of Cisplatin or Carboplatin With Gemcitabine in Combination With Irinotecan-loaded Beads (LC or ONCOZENE) Versus Cisplatin or Carboplatin With Gemcitabine Alone in the Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma

Long-term follow-up will occur every 3-4 months for up to one year after discontinuation of active study treatment. Subjects who have completed the long-term follow-up period will be monitored every 3 - 6 months until evidence of progression of disease. Once there is progression of disease subjects will be followed for overall survival by telephone or standard physician follow-ups as per standard of care until death.

University of Louisville

Robert C. Martin

Professor

Transarterial Chemoembolization (LC or ONCOZENE Bead) with Gem-Cis or Gem-Carbo

LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo

Randomization to LC OR ONCOZENE Bead With Gem-Cis or Gem-Carbo

Gem-Cis or Gem-Carbo alone

Gem-Cis or Gem-Carbo

Randomization to Gem-Cis or Gem-Carbo

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

All randomized subjects who receive at least one cycle of intravenous chemotherapy or LC or ONCOZENE beads loaded with irinotecan. Subjects will be grouped according to their randomization.

Overall Survival

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin	NCT01648023	Unresectable In...	LC or ONCOZENE ... Gem-Cis or Gem-...	18 Years -	University of Louisville
Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin	NCT01648023	Unresectable In...	LC or ONCOZENE ... Gem-Cis or Gem-...	18 Years -	University of Louisville

Spots Global Cancer Trial Database for oncozene bead