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

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

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.

Study Overview

• Status: Completed
• Conditions: Unresectable Intrahepatic Cholangiocarcinoma
• Intervention / Treatment: Device: LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo; Drug: Gem-Cis or Gem-Carbo

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor Response (Overall Response = Complete Response + Partial Response + Progressive Disease + Stable Disease)	Tumor response will be determined using Modified Response Evaluation Criteria in Solid Tumors (mRECIST). Response will be classified as: Complete Response - disappearance of all lesions; Partial Response - at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter or 30% reduction in arterial enhancement; Progressive Disease - at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest longest diameter recorded since start of treatment or appearance of one or more new lesions greater than 1cm in size; Stable Disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since start of treatment.	Assessed at 2, 4 and 6 months. 6 months reported.

Secondary 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.	4.5 Years

Collaborators and Investigators

• Sponsor: Robert C. Martin
• Collaborators: University of Louisville
• Investigators: Principal Investigator: Robert Martin, MD, PhD, University of Louisville

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: July 17, 2012
• First Submitted That Met QC Criteria: July 19, 2012
• First Posted (Estimated): July 24, 2012

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Irinotecan; LC Bead; ONCOZENE BEAD
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Cholangiocarcinoma
• Other Study ID Numbers: 11-0181

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes