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
Overview
- Phase
- Phase 2
- Intervention
- LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo
- Conditions
- Unresectable Intrahepatic Cholangiocarcinoma
- Sponsor
- Robert C. Martin
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- Tumor Response (Overall Response = Complete Response + Partial Response + Progressive Disease + Stable Disease)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Robert C. Martin
Professor
University of Louisville
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Randomization to LC OR ONCOZENE Bead with Gem-Cis or Gem-Carbo
Transarterial Chemoembolization (LC or ONCOZENE Bead) with Gem-Cis or Gem-Carbo
Intervention: LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo
Randomization to Gem-Cis or Gem-Carbo
Gem-Cis or Gem-Carbo alone
Intervention: Gem-Cis or Gem-Carbo
Outcomes
Primary Outcomes
Tumor Response (Overall Response = Complete Response + Partial Response + Progressive Disease + Stable Disease)
Time Frame: 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 Outcomes
- Overall Survival(4.5 Years)