E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-resectable or inoperable cholangiocarcinoma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008594 |
E.1.2 | Term | Cholangiocarcinoma non-resectable |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
- 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;
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 < 2 ULN 6. Patient with WHO Performance Scale ≤ 2 7. Patient in whom efficient drainage is performed by means of a plastic biliary stent endoscopically or radiologically 8. Patient capable of completing the quality of life questionnaires 9. 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). |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 15 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 15 |