Photodynamic Therapy (PDT) Trial for Palliation of Cholangiocarcinoma

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

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).

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).

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