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HAI-FUDR with Systemic Cisplatin and Gemcitabine for Cholangiocarcinoma
NCT01692704Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2012
- Primary completion
- Mar 2016
- Countries
- 1
- Sponsor
- University of Zurich
- Modality
- Small Molecules
- Drugs
- gemcitabine
- Conditions
- cholangiocarcinoma (CCA)gallbladder cancer
01
Overview
Phase 2, open-label, single-arm trial of gemcitabine in cholangiocarcinoma (CCA) and gallbladder cancer, sponsored by University of Zurich. Primary endpoint: Dose Limiting Toxicities at 6 weeks. Started Apr 2012; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
HAI with FUDR & systemic cisplatin and gemcitabin
FUDR: 0.2mg/kg/day continuously i.a. for 14 days. Cisplatin: 25mg/m2 i.v. Gemcitabine: 600, 800, or 1000 mg/m2 i.v.
03
Who it enrols
Adult patients with histologically proven unresectable intrahepatic or hilar cholangiocellular carcinoma (including gallbladder cancer) and adequate organ function.
04
Endpoints
Primary
Dose Limiting Toxicities
Secondary
Response Rate
Safety and Toxicity
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