Study Using WST11 in Patients With Non-Resectable or Inoperable Cholangiocarcinoma

• Status: Terminated
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Steba Biotech S.A.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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