Status:
TERMINATED
Study Using WST11 in Patients With Non-Resectable or Inoperable Cholangiocarcinoma
Lead Sponsor:
Steba Biotech S.A.
Conditions:
Cholangiocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The aim of this study is to evaluate the safety of Vascular Targeted Photodynamic therapy with WST11 in patients with non-resectable or inoperable biliary carcinoma.
Detailed Description
This is an open-label, prospective, multicentre, phase IIa study, evaluating a new therapeutic agent in the management of patients suffering from inoperable or non resectable biliary carcinoma. The pa...
Eligibility Criteria
Inclusion
- Patient having signed the consent form to take part in the study
- Patient aged over 18 years, with no upper age limit
- Patient with histologically proven cholangiocarcinoma
- Patient with cholangiocarcinoma, inoperable or non resectable owing to extension, age or concomitant diseases
- Bilirubin level decrease of more than 50% after stent insertion compared to base level
- Patient with a WHO Performance Scale ≤ 2
- Patient in whom efficient drainage is performed by means of a plastic biliary stent endoscopically or radiologically
- Patient capable of completing the quality of life questionnaires
- Women of child-bearing potential must have a negative pregnancy test, and must thereafter prove to be using acceptable contraception (oral contraceptive pill, hormone patches, or IUD)
Exclusion
- Absence of consent to take part in the study
- Patient with operable biliary carcinoma
- Class ASA IV patients
- Patients presenting clinical and laboratory signs of biliary infection
- Absence of bilirubin decrease after stent insertion
- Patients with extrinsic biliary compression
- Patients already having received or currently receiving radiotherapy or chemotherapy for cholangiocarcinoma or needing to be treated during the first month of the follow-up
- Known metastatic lesions
- Patients having received immediate treatment by insertion of a metal stent
- Patients with porphyria or known hypersensitivity to porphyrins (contraindication to WST11)
- Patient receiving prohibited treatment at the time of inclusion in the study
- Pregnant or breast-feeding women
- Non-menopausal women not using effective contraception
- Majors under protection as per the French Public Health Code
- Persons not registered with or covered by a social security system
- Persons in an exclusion period relative to other biomedical study
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00975039
Start Date
September 1 2009
End Date
September 1 2012
Last Update
April 18 2016
Active Locations (1)
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1
Clinique de l'Alma
Paris, France