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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Unresectable Intrahepatic Cholangiocarcinoma

Intervention / Treatment
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* Device: LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo
* Drug: Gem-Cis or Gem-Carbo


Participation Criteria
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Eligibility Criteria
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Inclusion: Patients over 18 years of age, of any race or sex, who have histologic and radiologic evidence of intrahepatic cholangiocarcinoma, who have been deemed unresectable by an experienced hepatic surgeon, and who are able to give informed consent, will be eligible Patients with at least one measurable liver tumor, with size > 1cm (modified RECIST criteria) Patients with liver-dominant disease defined as ≥80% tumor burden confined to the liver Non-pregnant with an acceptable contraception in premenopausal women. Hematologic function: ANC ≥ 1.5 x 109/L, platelets ≥ 75 x109/L, INR ≤1.3 (patients on therapeutic anticoagulants are not eligible if they can not stop there anti-coagulation prior to DEBIRI and meet INR criteria) Adequate liver function as measured by: Total bilirubin ≤ 2.0 mg/dl, Adequate renal function (creatinine ≤ 2.3 mg/dl) Women of child bearing potential and fertile men are required to use effective contraception (negative serum βHCG for women of child-bearing age) Signed, written informed consent Less than 70% of liver parenchymal tumor replacement Exclusion: Patient eligible for curative treatment (i.e. resection or tumor ablation). Active bacterial, viral or fungal infection within 72 hours of study entry Women who are pregnant or breast feeding ECOG Performance Status score of >3 Life expectancy of < 3 months Allergy to contrast media that cannot be managed with standard care (e.g. steroids), making magnetic resonance imaging (MRI) or computed tomography (CT) contraindicated Presence of another malignancy with the exception of cervical carcinoma in situ and stage I basal or squamous cell carcinoma of the skin. Any contraindication for hepatic embolization procedures: Large shunt as determined by the investigator (pretesting with TcMMA not required) Severe atheromatosis vascular disease that precludes arterial cannulization Hepatofugal blood flow Main portal vein occlusion (e.g. thrombus or tumor) Other significant medical or surgical condition, or any medication or treatment, that would place the patient at undue risk and that would preclude the safe use of chemoembolization or would interfere with study participation Patients with prior contraindications for the use of irinotecan, gemcitabine, or cisplatin Patients who have received prior systemic therapy with either irinotecan, gemcitabine, or cisplatin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Randomization to LC OR ONCOZENE Bead with Gem-Cis or Gem-Carbo<br>Transarterial Chemoembolization (LC or ONCOZENE Bead) with Gem-Cis or Gem-Carbo | Device: LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo<br> <br> |
| Active Comparator: Randomization to Gem-Cis or Gem-Carbo<br>Gem-Cis or Gem-Carbo alone | Drug: Gem-Cis or Gem-Carbo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | 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. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LC Bead, Irinotecan, ONCOZENE BEAD