Non-resectable or inoperable cholangiocarcinoma MedDRA version: 9.1 Level: LLT Classification code 10008594 Term: Cholangiocarcinoma non-resectable
Conditions
Sponsors
STEBA BIOTECH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient having signed the consent form to take part in the study 2. Patient aged over 18 years, with no upper age limit 3. Patient with histologically proven cholangiocarcinoma 4. Patient with cholangiocarcinoma, inoperable or non resectable owing to extension, age or concomitant diseases 5. Bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Absence of consent to take part in the study 2. Patient with operable biliary carcinoma 3. WHO Performance Scale > 2 4. Class ASA IV patients 5. Patients presenting clinical and laboratory signs of biliary infection 6. Bilirubin = 2 ULN 7. Patients with extrinsic biliary compression 8. Patients already having received or currently receiving radiotherapy or chemotherapy for cholangiocarcinoma or need to be treated during the first month of the follow-up 9. Known metastatic lesions 10. Patients having received immediate treatment by insertion of a metal stent 11. Patients with porphyria or known hypersensitivity to porphyrins (contraindication to WST11) 12. Patient receiving prohibited treatment at the time of inclusion in the study 13. Pregnant or breast-feeding women 14. Non-menopausal women not using effective contraception 15. Patient aged less 18 years 16. Majors under protection as per the French Public Health Code 17. Persons not registered with or covered by a social security system 18. Persons in an exclusion period relative to other biomedical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Evaluate the safety through analysis of adverse events (clinical laboratory tests, electrocardiogram, physical examination, absence of local or general complications and phototoxicity) of WST11 in inoperable or non resectable cholangiocarcinoma. ;Main Objective: To evaluate the safety of photodynamic therapy with WST11 administered according to two treatment regimens in patients with cholangiocarcinoma considered non-resectable or inoperable and drained previously by insertion of a plastic stent. The primary evaluation endpoint corresponds to the safety as evaluated through analysis of adverses events,clinical laboratory tests,electrocardiogram and physical examination at 0, 1, 3 and 6 months. ;Secondary Objective: - To evaluate the efficacy of photodynamic therapy by comparing the objective response rate on the tumor after 1, 3 and 6 months. - To evaluate the effect on cholestasis and the incidence of biliary complications of obstructive origin, by comparing bilirubin levels and the number of episodes of biliary obstruction after 6 months of follow-up. - To evaluate the effect of treatment on patient quality of life by comparing the score obtained by the QLQ-C30 self-questionnaire after 1, 3 and 6 months. - To evaluate the global survival at month 6 after WST11 mediated VTP; | — |
Countries
France
Outcome results
None listed