Evaluation of the Safety and Efficacy of WST11-mediated Vascular Targeted Photodynamic Therapy in Non-resectable or Inoperable Cholangiocarcinoma
18 Years
N/A
Both
Cholangiocarcinoma
Trial Information
Evaluation of the Safety and Efficacy of WST11-mediated Vascular Targeted Photodynamic Therapy in Non-resectable or Inoperable Cholangiocarcinoma
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 patients will receive the dose of WST11 according to order of
inclusion. The first 3 patients will receive 2.5 mg/kg. In the absence of toxicity, the
following 9 patients will receive the dose of 5 mg/kg.
The patient is to receive anesthesia. WST11-mediated therapy will consist of the
combination of single IV administration of WST11 at doses of 2.5mg/kg or 5mg/kg, using 753nm
laser light at a fixed power of (150mW/cm) and light energy (200 J/cm) delivered through a
diffusing fiber. The fiber is introduced in a transparent standard ERCP catheter and
positioned under radioscopy in front of the lesion.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome 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
Outcome Time Frame:
Patient inclusion - Month 6
Safety Issue:
Yes
Principal Investigator
Emmanuel Ben Soussan, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Clinique de l'Alma
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
CLIN904 CCM201
NCT ID:
NCT00975039
Start Date:
September 2009
Completion Date:
September 2012
Related Keywords:
- Cholangiocarcinoma
- Inoperable
- Inoperable Cholangiocarcinoma
- Non-resectable
- Non-resectable Cholangiocarcinoma
- Carcinoma
- Cholangiocarcinoma
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