Your session is about to expire
← Back to Search
Alkylating agents
Percutaneous Hepatic Perfusion vs. Cisplatin/Gemcitabine in Patients With Intrahepatic Cholangiocarcinoma
Phase 2 & 3
Waitlist Available
Research Sponsored by Delcath Systems Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pfs change will be assessed every 9 weeks through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare two groups of patients with intrahepatic cholangiocarcinoma, one of which will receive high-dose chemotherapy delivered specifically to the liver. The other group will continue with the standard cisplatin and gemcitabine treatment. The results will be measured in terms of overall survival.
Eligible Conditions
- Liver Cancer
- Cholangiocarcinoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ orr change will be assessed every 9 weeks through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~orr change will be assessed every 9 weeks through study completion, an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Survival
Secondary study objectives
Objective response rate (CR + PR) as determined by the Investigator
Progression-free survival, as determined by IRC
Other study objectives
Incidence of Treatment-Emergent Adverse Events (Safety)
Objective response rate as determined by IRC
Pharmacokinetic Outcome Measures: AUC
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Melphalan/PHPExperimental Treatment1 Intervention
Patients may receive up to 6 treatments of Melphalan/HDS 3.0 mg/kg IBW. Each treatment cycle consists of 6 weeks with an acceptable delay for an additional 2 weeks (i.e. 8 weeks in total). The maximum dose of melphalan will be 220 mg per treatment.
Group II: Cisplatin and GemcitabineActive Control1 Intervention
Each Cis/Gem treatment cycle will comprise cisplatin, dosed at 25 mg per square meter of body surface area, and gemcitabine, dosed at 1000 mg per square meter of body surface area. Each will be administered on Days 1 and 8 every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melphalan/HDS
2016
Completed Phase 3
~110
Find a Location
Who is running the clinical trial?
Delcath Systems Inc.Lead Sponsor
9 Previous Clinical Trials
588 Total Patients Enrolled
1 Trials studying Cholangiocarcinoma
17 Patients Enrolled for Cholangiocarcinoma