Photodynamic Therapy (PDT) Trial for Palliation of Cholangiocarcinoma

Study Overview
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Brief Summary
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This research study is a phase III double arm, multicenter, randomized controlled clinical trial comparing endoscopic retrograde cholangiopancreatography (ERCP) and stenting plus photodynamic therapy (PDT) versus ERCP with stenting alone in adult patients with unresectable cholangiocarcinoma. The study objectives are to investigate the efficacy of photodynamic therapy (PDT) in increasing the survival time of patients with unresectable cholangiocarcinoma and to assess the effect of PDT on both cholestasis and health-related quality of life (HRQoL).

Detailed Description
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The study objectives are to investigate the efficacy of photodynamic therapy (PDT) in increasing the survival time of patients with unresectable cholangiocarcinoma and to assess the effect of PDT on both cholestasis and health-related quality of life (HRQoL).

Official Title
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Photodynamic Therapy for Palliation of Unresectable Cholangiocarcinoma A Multicenter, Open Label, Randomized, Controlled Phase III Trial

Conditions
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Cholangiocarcinoma

Intervention / Treatment
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* Procedure: ERCP and Photodynamic Therapy
* Procedure: ERCP only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is age 18 years or older Patient is diagnosed with non-resectable cholangiocarcinoma, as determined by CT within 30 days of enrollment and CT shows Bismuth Tumor Stage as: IIIa, IIIb, IV (Bismuth tumor stage I and II are not eligible to participate) Patients must have adequate organ and marrow function as defined below: Patient's INR ≤ 2 within 30 days of treatment Patient's platelets > 50,000/cmm within 30 days of treatment Patient's Absolute Neutrophil Count (ANC) > 1,500/cmm within 30 days of treatment Patient's creatinine ≤ 3 mg/dL within 30 days of treatment Patient has the ability to understand and the willingness to comply with the study procedures and provide written informed consent to participate in the study Exclusion Criteria: Patient was diagnosed with cholangiocarcinoma more than 3 months ago Patient has any metastatic disease Patient has acute porphyria Subjects exhibiting neurologic or cutaneous symptoms will undergo urinary delta-aminolevulinic acid and porphobilinogen dosage tests to determine severity. Patient is pregnant (Women of child bearing age must have a negative pregnancy test prior to registration and must agree to use adequate contraception during study therapy) Patient has a concurrent non solid malignancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERCP and PDT<br>Endoscopic Retrograde Cholangio Pancreatography (ERCP) and stenting combined with Photodynamic Dynamic Therapy ERCP and PDT | Procedure: ERCP and Photodynamic Therapy<br>* Photodynamic Therapy is a new therapeutic approach that specifically targets neoplastic cells. This therapy has been used in other tumors as a local treatment and involves the intravenous administration of a photosensitizing agent followed by activation of the agent by illumination with non-thermal light of a specific wavelength, resulting in cell death from direct cytotoxicity and ischemic necrosis. Cytotoxicity is directly proportional to tissue oxygenation.<br>Procedure: ERCP only<br>* Endoscopic retrograde cholangiopancreatography and stenting.<br>|
| Active Comparator: ERCP alone<br>Endoscopic Retrograde Cholangio Pancreatography (ERCP) with stenting alone | Procedure: ERCP only<br>* Endoscopic retrograde cholangiopancreatography and stenting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival time in each group will be compared as well as effect of each treatment arm on cholestasis and HRQoL |  | 2.4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, bile duct