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

Phase 2

Completed

• Conditions: Unresectable Intrahepatic Cholangiocarcinoma
• Interventions: Device: LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo; Drug: Gem-Cis or Gem-Carbo

• Registration Number: NCT01648023
• Lead Sponsor: Robert C. Martin

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-17
• Study First Submitted QC: 2012-07-19
• Study First Posted: 2012-07-24
• Primary Completion: 2019-01
• Study Completion: 2019-09
• Results First Submitted: 2021-10-08
• Status Verified: 2021-12
• Results First Submitted QC: 2021-12-14
• Results First Posted: 2022-01-13
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Randomization to LC OR ONCOZENE Bead with Gem-Cis or Gem-Carbo	LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo	Transarterial Chemoembolization (LC or ONCOZENE Bead) with Gem-Cis or Gem-Carbo
Randomization to Gem-Cis or Gem-Carbo	Gem-Cis or Gem-Carbo	Gem-Cis or Gem-Carbo alone

Primary Outcome Measures

Name	Time	Method
Tumor Response (Overall Response = Complete Response + Partial Response + Progressive Disease + Stable Disease)	Assessed at 2, 4 and 6 months. 6 months reported.	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	4.5 Years	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.

Trial Locations

Locations (1)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States