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

NCT ID: NCT01648023

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2019-09-30

Brief Summary

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.

Conditions

Unresectable Intrahepatic Cholangiocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Randomization to Gem-Cis or Gem-Carbo

Gem-Cis or Gem-Carbo alone

Group Type: ACTIVE_COMPARATOR

Gem-Cis or Gem-Carbo

Intervention Type: DRUG

Interventions

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

Intervention Type: DEVICE

Gem-Cis or Gem-Carbo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Robert C. Martin

OTHER

Sponsor Role: lead

Responsible Party

Robert C. Martin

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Robert Martin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

University of Louisville

Louisville, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

11-0181

Identifier Type: -

Identifier Source: org_study_id