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

Steba Biotech

Status and phase

Terminated

Phase 2

Conditions

Cholangiocarcinoma

Treatments

Drug: WST11

Study type

Interventional

Funder types

Other

Identifiers

NCT00975039

CLIN904 CCM201

Details and patient eligibility

About

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.

Full description

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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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