Clinical trial · Interventional
Study Using WST11 in Patients With Non-Resectable or Inoperable Cholangiocarcinoma
Evaluation of the Safety and Efficacy of WST11-mediated Vascular Targeted Photodynamic Therapy in Non-resectable or Inoperable Cholangiocarcinoma
NCT00975039CI-TRIAL-00021801terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Early end of enrolment with regards to difficulty met to enrol patients .
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| WST11 | Drug | Padeliporfin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- WST11
- description
- Treatment with WST11-mediated VTP
- interventionNames
- Drug: WST11
Primary outcomes (1)
- measure
- Evaluation of the safety based on 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
- timeFrame
- Patient inclusion - Month 6
Secondary outcomes (4)
- measure
- Evaluation of the antitumor efficacy of WST11-mediated VTP therapy by comparing the objective response rate on the tumor.
- timeFrame
- Month 1, Month 3 & Month 6
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.